medtronic grafton dbm putty

(Available bone harvested from your body may be limited.). Device Name: DBM A43205 0.5CC GRAFTON PUTTY SYRINGE. Medtronic follows AATB guidelines in sourcing donors and works to maximize the use of donated tissue. . Martin, G.J. medtronic, inc. ("medtronic") offers remoteview, which permits a user ("programmer user") of the medtronic carelink 2090 programmer ("programmer") to allow the viewing of information presently displayed on the programmer screen with one or more individuals in remote locations anywhere in the world ("remote viewer"), including remote health care GRAFTON DBM and GRAFTON PLUS DBM are absorbed/remodeled and replaced by host bone during the healing process. Bacterial infection at the graft site may also occur. Products Caution: GRAFTON DBM DBF is restricted to use by a physician, podiatrist, or dentist. We are a liquidator of sutures (and other surgical items) from Medtronic/Covidien, Stryker, Arthrex - and many more - and are able to pass our savings on to you. Catalog Number: Company Name: MEDTRONIC SOFAMOR DANEK, INC. Primary DI Number: 00613994986214. Commercial Distribution End Date: 2 10/18/2012 Osteotech Inc Grafton DBM Gel Multiple Sizes Grafton is a human bone allograft product containing demineralize Grafton DBM is a bone graft extender, bone graft substitute, and bone void filler in bony voids or gaps of the skeletal system (i.e., spine, pelvis, and extremities). ZERO BIAS - scores, article reviews, protocol conditions and more . The presence of infection at the transplantation site. Contraindications Product processing consistency is confirmed via ongoing testing.. The presence of infection at the implantation site is a contraindication for the use of this allograft. Scarborough N, White E, Hughes J, Manrique A, Poser J. Allograft Safety: Viral Inactivation with Bone Demineralization. Medtronic Sofamor Danek PROGENIX Plus 510(k) Summary . Recommended ratios of GRAFTON PLUS DBM Paste to autograft as a bone graft extender are 1:1 or 2:1. Common Uses: Spine, trauma, pelvis, extremities. The product can also be used in bone grafting procedures in combination with autologous bone or other forms of allograft bone, or alone as a bone graft. For more details see Indications, Safety, and Warnings. Learn more about how Grafton DBF Inject can improve your workflow and operating room (OR) efficiencies (4:48). Medtronic grafton dbm Grafton Dbm, supplied by Medtronic, used in various techniques. The following are contraindications for the use of GRAFTON DBM and GRAFTON PLUS DBM: Medtronic Operational Headquarters 710 Medtronic Parkway Minneapolis, MN 55432-5640 USA, Central/Eastern Europe, Middle East & Africa, Electromagnetic Compatibility Guide for Cardiac Devices, Electromagnetic Compatibility for Cardiac Devices, California Transparency in Supply Chains Act, Information About Proposition 65 for California Customers, Digital Millennium Copyright Act (DMCA) Notification. Grafton NuVasive Propel DBM putty- no specific code: . Despite the viral inactivation and extensive tissue donor selection and qualification processes used in providing this tissue graft, transmission of a communicable disease through the use of this tissue graft is still possible. This allograft may contain trace amounts of antibiotics (gentamicin), surfactant, and other processing solutions. Commercial Distribution End Date: Device Count: 1. And a fiber technology proven to be osteoconductive in a preclinical outcomes study. Bone Grafting Bone Grafting Grafton DBM is a bone graft extender, bone graft substitute, and bone void filler in bony voids or gaps of the skeletal system (i.e., spine, pelvis, and extremities). Medtronic Sofamor Danek USA, Inc. Acrobat . It is readily available. Allograft bone is well documented in clinical studies and has an excellent safety record. Proposed Proprietary Trade Name: MASTERGRAFT Putty Khan SN, Fraser JF, Sandhu HS, Cammisa FP, Girardi FP, Lane JM. Find these technical manuals in the Medtronic Manual Library, in the product labeling supplied with each product, or by calling Medtronic at800-961-9055. Manufacturer Units in stock: 5 . Company Name: MEDTRONIC SOFAMOR DANEK, INC. Primary DI Number: 00643169134560 Issuing Agency: GS1 Commercial Distribution End Date: . Grafton DBF Inject can be used in orthopaedic or reconstructive bone grafting procedures. With an updated browser, you will have a better Medtronic website experience. Update my browser now. Grafton DBF Inject and its patented* fiber technology enables the first flowable carrier free Fiber DBM on the market today. AccessGUDID - GRAFTON DBM (00643169134560)- DBM T43103INT 2.5CC GRAFTON PUTTY. Cammisa, et al. Grafton DBF Inject can be used in orthopaedic or reconstructive bone grafting procedures. Home 1999;24(7):637-645. Bacterial infection at the graft site may also occur. 2004;29(6):660-666. Instructions for use and product manuals for healthcare professionals. Osteotech Inc, 51 James Way, Eatontown NJ 07724-2272. Manufacturer Address. Two-year fusion rate equivalency between Grafton DBM Gel and autograft in posterolateral spine fusion. No more worrying about manual recordkeeping the Smartstorage System keeps accurate usage history and temperature logs. Order Qty. Donors were grouped in the age ranges specified. Extensive donor blood serum testing, medical and social history screening procedures, and tissue microbiological testing have been used in the qualification of all tissue donors. this information to additional personnel within their facility as appropriate and return the questionnaire to Medtronic.. Customers with questions should contact their Medtronic Sales Representative at 800-876-3133, extension 3197. The presence of infection at the transplantation site is a contraindication for the use of this allograft. Find bone grafting education and training resources from Medtronic. Our bone graft options span osteoinduction, cell promotion, and cell enhancements to cell delivery, resulting in fusion success. * Our aseptic processing technology preserves the function of naturally occurring growth factors yielding Grafton DBMs consistently high osteoinductivity scores. Proprietary fiber technology offers enhanced osteoconductive scaffold.1. Interested in trying it? Grafton DBM products, Magnifuse Bone Graft, Xpanse Bone Insert, Mastergraft Matrix ongoing final product testing (2006-2014); Accell Connexus , three manufacturing lots tested on 2005; Accell Evo3 c, three manufacturing lots tested on 2010/2014; Intergro Putty, one manufacturing lot tested on 2004; Accell Allograft bone is well documented in clinical studies and has an excellent safety record. Based on internal testing in an athymic rat model. This graft comes pre-loaded in a syringe with minimally invasive accessories that allow the product to be delivered through most retractor systems and helps facilitate spine fusion procedures, as well as any bone voids where fusion/union is desired. Any adverse outcomes potentially attributable to GRAFTON DBM or GRAFTON PLUS DBM must be reported promptly to Medtronic. Expired. Therefore, malalignment of length and axis can Therefore, caution should be exercised in using GRAFTON PLUS DBM Paste in a patient with a starch allergy and/or amylase deficiency. Units in stock: 5 box of 5. Therefore, caution should be exercised in using GRAFTON PLUS DBM Paste in a patient with a starch allergy and/or amylase deficiency. We are a liquidator of sutures (and other surgical items) from Medtronic/Covidien, Stryker, Arthrex - and many more - and are able to pass our savings on to you. The proprietary demineralization process inactivates viruses while preserving the osteoinductive activity necessary for new bone formation. The product can also be used in bone grafting procedures in combination with autologous bone or other forms of allograft bone, or alone as a bone graft. Medtronic Bihlermed Scintillant Suction, IPX5. GRAFTON DBF INJECT . There are no specific warnings, precautions, or adverse effects associated with the use of this device. Brand Name: GRAFTONand GRAFTON PLUSDemineralized Bone Matrix (DBM) Version or Model: T43110. Medtronic GRAFTON (R) DBM, Flex 2.5cm x 10cm, REF T42100, Rx only, STERILE A, QTY: 1 EA, Medtronic S. 2 02/12/2014 . Using Grafton DBM eliminates the need for a second surgical site to harvest, or remove surgically, bone from your body (autogenous bone) for placement at the oral surgery site. You dont need a second surgery to harvest bone from another place in your body (Grafton is used with existing local bone harvested at the surgical site). Grafton DBM is the first ever demineralized bone matrix product available in Japan, which is the world's second largest Treatment of spinal insufficiency fractures. Spine. Grafton Putty consists of demineralized bone fibers and can be mixed with either allograft or autograft bone. Grafton DBF Inject outperforms competitors in the areas of delivery, hydration, fibers, and sterilization. The orange bars represent results from female donors and the blue bars represent male donors.7. Medtronic BihlerMed Scintillant Zip-Strap Surgical Light. Device Name: DBM T43105 5CC GRAFTON PUTTY. (2004) conducted a prospective equivalency trial of Grafton DBM and iliac crest autograft in spine fusion, with each patient serving . Grafton DBM is the most utilized DBM brand available. Our aseptically processed fibers have some of the highest osteoinductive scores1 of all the products we have testedand this interconnected mesh of fibers enhances the osteoconductive potential of the product by providing a path for cellular infiltration.2. Less information (see less), Learn more about how Grafton DBF Inject can improve your workflow and operating room (OR) efficiencies (4:48). Skip to Main Content; National Library of Medicine NLM Tools and Resources . Product performance matters. *Third party brands are trademarks of their respective owners. best www.medtronic.com. Issuing Agency: GS1. Medtronic Allograft Tissue covers surgical procedures in spinal, orthopedic, sports medicine, and dental applications literally from head to toe. L'objectif de cette tude est d'valuer la scurit et la performance de NuVasive interbody implants lorsqu'ils sont utiliss pendant une chirurgie . GRAFTON DBM is substantially equivalent, for the purpose of this 510(k), to other devices that have received 510(k) clearance for similar indications for use. 2658-01-0002. Grafton Gel can be injected percutaneously and can be mixed with cancellous chips. Grafton DBM Putty, Grafton DBM Gel, Grafton DBM Flex, Grafton DBM A-FlexTM, Grafton DBM Crunch, Grafton DBM Matrix PLF, Grafton DBM Matrix Strips, Grafton DBM Orthoblend, Grafton Plus DBM Paste . equivalent to previously cleared bone void fillers such as PROGENIX DBM Putty (Medtronic Sofamor Danek, K072265, SE 01/09/08)and GRAFTON DBM Crunch (Osteotech, Inc., K051195, SE 12/16/05). Osteoinductivity Potential All DBM used in the preparation of PROGENIX Plus must induce . Grafton Plus DBM Paste contains starch. Treatments & Therapies It can be used with certain Medtronic interbody devices, when hydrated with bone marrow aspirate (BMA) for spinal and orthopedic procedures. We are a liquidator of sutures (and other surgical items) from Medtronic/Covidien, Stryker, Arthrex - and many more - and are able to pass our savings on to you. Medtronic Bihlermed Scintillant Suction, IPX5. Over-pressurize the defect site, as this may lead to fat embolization or embolization of the device material into the bloodstream. MEDTRONIC GRAFTON DBM PUTTY, 1CC. Once the user has seen at least one product this snippet will be visible. The presence of infection at the transplantation site. Bioz Stars score: 88/100, based on 1 PubMed citations. 1995 Oct; 31(4): 257-61. In addition, it is designed to facilitate the premixing of bone graft materials with fluids such as I.V. Osteoinductivity scores for each age group and gender were determined using an in vivo athymic rat assay. Device Identifier (DI) Information. Our unique syringe design allows for seamless hydration and delivery of our premium, Grafton DBF bone graft. It offers several benefits: GRAFTON DBM and GRAFTON PLUS DBM are intended for use as a bone graft extender, bone graft substitute, and bone void filler in bony voids or gaps of the skeletal system (i.e., spine, pelvis, and extremities) not intrinsic to the stability of the bony structure. Allograft Tissue Resource Center | Medtronic . Process variables include: At Medtronic, we use our proprietary D-Min process to demineralize the allograft tissue that goes into the different Grafton DBM forms. spine, pelvis, extremities) not intrinsic to the stability of the bony structure. GRAFTON DBM PUTTY: Type of Device: BONE GRAFTING MATERIAL, HUMAN SOURCE: Manufacturer (Section D) OSTEOTECH, INC (SUBSIDIARY OF MEDTRONIC) 51 james way: GRAFTON DBM DBF can be used in orthopedic or reconstructive bone grafting procedures. Based on Pub-Med search on 8/26/14 with keywords Grafton, DBX and Osteosponge. Commercial Distribution Status: Not in Commercial Distribution. Device Identifier (DI) Information. Despite the viral inactivation and extensive tissue donor selection and qualification processes used in providing this tissue graft, transmission of an infectious disease through the use of this tissue graft is still possible. Unique syringe design allows for precise delivery of our premium, highly osteoinductive DBM fiber, into traditionally difficult to access sites. The product can also be used in bone grafting procedures in combination with autologous bone or other forms of allograft bone, or alone as a bone graft. Data on file. Update my browser now. The launch came. Grafton DBM. Grafton Add to compare list. Bioz Stars score: 86/100, based on 1 PubMed citations. Osteoinduction of human demineralized bone: characterization in a rat model. The Graft Preparation and Delivery Device is intended for the delivery of hydrated allograft, autograft or synthetic bone graft materials to an orthopaedic surgical site. See how easy it is to hydrate and deliver Grafton DBF Inject into the disc space for open and MIS spinal procedures (3:27). Miscellaneous - Medtronic - eSutures - The Suture Superstore pdf Canada CTO Registration Certificate (.pdf) 2.8MB. In addition, the processing is performed using aseptic techniques that results in a highly osteoinductive. Grafton DBM Putty Multiple Sizes Grafton is a human bone allograft product containing deminerali. Grafton DBF Inject. Global Unique Device ID: 00643169123151. Version (Model) Number: A43205. Medtronic grafton demineralized bone matrix dbm putty Grafton Demineralized Bone Matrix Dbm Putty, supplied by Medtronic, used in various techniques. Medtronic's processing facility, located in Eatontown, New Jersey, is accredited by the American Association of Tissue Banks (AATB), and is committed to providing quality and innovation in its various demineralized bone matrix tissue forms. Products These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone, including periodontal/infrabony defects; alveolar ridge augmentation (sinusotomy, osteotomy, cystectomy); dental extraction sites (ridge maintenance, implant preparation/placement); sinus lifts; cystic defects; craniofacial augmentation. Kang J, An H, Hilibrand A, Yoon ST, Kavanagh E, Boden S. Grafton and local bone have comparable outcomes to iliac crest bone in instrumented single-level lumbar fusions. Medtronic was the first to market with a fiber based DBM. The voids or gaps may be surgically created defects or defects created by traumatic injury to the bone. Caution should be exercised if the patient is allergic to these antibiotics or chemicals. Bone Grafting Two grafts per package. What Is It It is comprised of multiple forms, each with unique handling characteristics designed to extend or replace autogenous bone in a variety of challenging bone grafting procedures. It is used for spinal and orthopedic procedures. Medtronic plc MDT recently announced the launch of the Grafton demineralized bone matrix (DBM) bone grafting product in Japan. Background Comminuted femoral fractures pose a challenge to the trauma surgeon due to the absence of bony references during surgery. By eliminating the glycerol carrier, Grafton DBF Inject improves on the groundbreaking Grafton DBM technology by producing a more versatile osteoinductive bone graft.1. Manuals may be available in additional languages, depending on the locale selected. Healthcare Professionals Any adverse outcomes potentially attributable to GRAFTON DBM or GRAFTON PLUS DBM must be reported promptly to Medtronic. in spinal fusions as an alternative to allograft. The product can also be used in bone grafting procedures in combination with autologous bone or other forms of allograft bone, or alone as a bone graft. Please select the locale. Grafton Putty (Medtronic) Test Article Lot # Average OI Score Group Std Dev Grafton Putty: TA IA OTSCT0709144036 Tissue Bank A 0.5 0.5 Grafton Putty: TA IB OTSCT0704164035 Tissue Bank A 0.43 0.53 Grafton Putty: TA IC OTSLN0832304037 Tissue Bank B 0.63 1.06 Table 2: Grafton Putty Osteoinductivity Scores. GRAFTON DBM and GRAFTON PLUS DBM may be used alone in a manner comparable to autogenous bone chips or allograft bone particulate (demineralized freeze dried bone), or they may be mixed with either allograft or autograft bone or bone marrow as a bone graft extender. FDA Documents - 510(k . Grafton Strips are long, narrow strips of demineralized bone matrix that overlap for contiguous bone graft contact. The voids or gaps may be surgically created defects or defects created by traumatic injury to the bone. Through a prospective randomized study of production allograft, we were able to validate that the D-Min process yields a consistently osteoinductive product. If injecting GRAFTON DBM or GRAFTON PLUS DBM into the defect site, precaution should be taken not to: When used as a bone graft extender in bony voids or gaps of the skeletal system (i.e., spine, pelvis, and extremities), GRAFTON PLUS DBM Paste is intended for use only with autograft, not other allograft. Allograft bone is well documented in clinical studies and has an excellent safety record. This allograft may contain trace amounts of antibiotics (gentamicin), surfactant, and other processing solutions. Animal testing is not necessarily indicative of human clinical outcome. Catalog Number: Company Name: MEDTRONIC SOFAMOR DANEK, INC. Primary DI Number: 00643169123175. The contents of an individual GRAFTON DBM DBF container are intended for single patient use only. SM Chip Size: 0.1mm4mm. Expired. Martin GJ, Boden SD, Titus L, Scarborough NL New Formulations of Demineralized Bone Matrix as a More Effective Graft Alternative in Experimental Posterolateral Lumbar Spine Arthrodesis. Medtronic - eSutures - The Suture Superstore By eliminating the need for a bone funnel and tamp, Grafton DBF inject has the potential to reduce the number of steps needed to deliver bone graft and improve OR efficiencies. The following are contraindications for the use of GRAFTON DBM and GRAFTON PLUS DBM: Grafton DBF can be used in orthopedic or reconstructive bone grafting procedures. Because allograft tissue processing, including demineralization, has evolved over time and is performed by numerous processors, it is important to recognize that not all demineralization processes are alike. Bacterial infection at the graft site may also occur. SEE RESOURCES CONTRAINDICATIONS An sterile implantable device made primarily of human demineralized bone matrix (DBM) (acid extraction of allogeneic bone resulting in loss of most of the mineralized component but retention of proteins) intended to fill bony voids or gaps caused by trauma or surgery, including use in the maxillofacial and/or mandibular bone. This allograft may contain trace amounts of antibiotics (gentamicin) and processing solutions. VI. With the proprietary D-MIN process, Grafton consistently scores high osteoinductivity*, which is an important part of bone fusion. Common Uses: Spine, Trauma, Pelvis, Extremities. Spinal & Orthopaedic Recommended ratios of GRAFTON PLUS DBM Paste to autograft as a bone graft extender are 1:1 or 2:1. Cammisa FP, Lowery G, Garfin SR, Geisler FH, Klara PM, McGuire RA, Sassard WR, Stubbs HA, Block JE. Grafton is used with existing local bone harvested at the surgical site. Brand Name: GRAFTONand GRAFTON PLUSDemineralized Bone Matrix (DBM) Version or Model: T43102. LG Chip Size: 2mm10mm. There is a limited possibility of disease transmission related to the use of human-derived material. Grafton (Demineralized Bone Fiber) DBF Inject is a demineralized bone allograft consisting of demineralized cortical fibers derived from cadaveric donor. Brand Name: GRAFTONand GRAFTON PLUSDemineralized Bone Matrix (DBM) Version or Model: A45010. GRAFTON PLUS DBM Paste contains starch. Visit the Allograft Resource Center for resources you may need to download. Manufacturer GRAFTON DBM and GRAFTON PLUS DBM are intended for use as a bone graft extender, bone graft substitute, and bone void filler in bony voids or gaps of the skeletal system (i.e., spine, pelvis, and extremities) not intrinsic to the stability of the bony structure. Over-pressurize the delivery device, as this may lead to extrusion of the device beyond the site of its intended application and damage to the surrounding tissues. Caution should be exercised if the patient is allergic to these antibiotics or chemicals. Catalog Number: Company Name: MEDTRONIC SOFAMOR DANEK, INC. Primary DI Number: 00643169123144. In August 2018, Medtronic secured approval from Pharmaceuticals and Medical Devices Agency (PDMA) for Grafton DBM, which is claimed to be the first and only demineralized bone matrix product available in Japan. Sponsors: Lead Sponsor: NuVasive Source: NuVasive Brief Summary: The objective of this study is to evaluate the safety and performance of NuVasive interbody implants when used during thoracic and/or lumbar spine surgery as measured by reported complications, radiographic outcomes, and patient-reported outcomes. GRAFTON DBM and GRAFTON PLUS DBM may be used alone in a manner comparable to autogenous bone chips or allograft bone particulate (demineralized freeze dried bone), or they may be mixed with either allograft or autograft bone or bone marrow as a bone graft extender. Treatment of spinal insufficiency fractures. Therefore, caution should be exercised in using Grafton Plus DBM Paste in a patient with a starch allergy and/or amylase deficiency. With a particular focus on spinal, trauma, and total joint revision procedures . and anterior lumbar interbody fusion (ALIF) procedures at a single level (Medtronic, 2018). Email a friend. Registre des essais cliniques. et al. Home The contents of an individual GRAFTON DBM DBF container are intended for single patient use only. Grafton Flex is a flexible sheet that can be applied whole, or cut into strips or smaller pieces. Spine 2012;37:1083-91. MEDTRONIC SOFAMOR DANEK, INC. Company name associated with the labeler DUNS Number entered in the . Use of osteopromotive growth factors, demineralized bone matrix, and ceramics to enhance spinal fusion. Proprietary fiber technology offers enhanced osteoconductive scaffold. Grafton DBF Inject is a precisely controlled bone graft delivery system that enables pre- and post-packing of graft material in the interbody space through integrated cannulas. Global Unique Device ID: 00643169068636. Healthcare Professionals Medtronic Sofamor Danek PROGENIX TM DBM Putty 510(K) Summary -K060794 December 2006 I. The following are contraindications for the use of GRAFTON DBM and GRAFTON PLUS DBM: This allograft may contain trace amounts of antibiotics (gentamicin), surfactant, and other processing solutions. Acid concentration and soak time for demineralization, Application of defatting agents such as ethanol, Aseptic processing methods versus those employing ethylene oxide or terminal sterilization. Grafton DBM DBF Indications, Safety, and Warnings, Grafton DBM DBF Indications, Safety, and Warnings. : DEPARTMENT OFHEALTH &HUMAN SERVICES Public Health Service . Our aseptically processed fibers have some of the highest osteoinductive scores on the market and this interconnected mesh of fibers enhances the osteoconductive potential of the product by providing a path for cellular infiltration. Chip Size: 2mm4mm Grafton family of DBM's were the first fiber-based DBM's on the market. GRAFTON PLUS DBM Paste (Osteotech, K040348, SE 11/23/05) and OSTEOFIL DBM Paste (Regeneration Technologies, Inc., K043420, SE 01/10/05). Any adverse outcomes potentially attributable to GRAFTON DBM DBF must be reported promptly to Medtronic. Manufacturer comment. Home With an updated browser, you will have a better Medtronic website experience. Note: The user should consider the fact that GRAFTON DBM CRUNCH contains demineralized bone chips approximately 3 mm (1 mm) in determining the appropriateness of this allograft for use in small defects. Find coding and reimbursement resources for physicians and hospitals from Medtronic SpineLine.. Contemp Orthop. If your locale is not listed, please contact your Medtronic sales representative or your local Medtronic office for technical support on Medtronic products. 2658-01-0002. Products For questions regarding this recall call 732-542-2800. Grafton, 1cc Putty (43102) Item # : GR-PT1. Available in two distinct formulations, Grafton Orthoblend combines demineralized bone fibers with cancellous chips or crushed cancellous chips. Grafton TM Demineralized Bone Matrix (DBM) is an allograft tissue, which means it is from a human donor, and thoroughly tested and processed to ensure safety and sterility. Clin Orthop Relat Res. We also offer a . GRAFTON PLUS DBM Paste contains starch. Download to view a summary of preclinical evidence for bone formation with Grafton DBF Inject. Two grafts per package. "If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal . The product can also be used in bone grafting procedures in combination with autologous bone or other forms of allograft bone, or alone as a bone graft. Medtronic conducted an extensive study assessing the impact of age and gender on osteoinductivity. Minimally invasive multilevel percutaneous correction and fusion for adult lumbar degenerative scoliosis: a technique and feasibility study. Choosing Grafton DBM eliminates the need for the second harvest surgery, avoiding the pain and bodily harm associated with the bone harvest procedure. Grafton DBM received PMDA approval in August 2018. Putty DBM/Autograft fusion masses, and appeared more mature (more osteoblastic activity and less . The volume of graft material used in each procedure is determined by the judgment of the clinician. Extensive donor blood serum testing, medical and social history screening procedures, and tissue microbiological testing have been used in the qualification of all tissue donors. QUICK VIEW. Company: Medtronic Sofamor Danek USA, Inc. . Photo: Courtesy of Medtronic. potential applications TLIF J Spinal Disord Tech 2008;21:459-67. 3 GraftonDBF Inject has higher OI than all competitors tested* OSTEOINDUCTIVITY BY PRODUCT* 1999;24(7):637-645. Over-pressurize the delivery device, as this may lead to extrusion of the device beyond the site of its intended application and damage to the surrounding tissues. - (03:27), More information (see more) Treatment of spinal insufficiency fractures. Extensive donor blood serum testing, medical and social history screening procedures, and tissue microbiological testing have been used in the qualification of all tissue donors. Validated process consistently produces an osteoinductive finished allograft. After Grafton DBM is implanted, cells migrate into the allograft material and remodel it into new bone. Traianedes K, Russell JL, Edwards JT, Stubbs HA, Shanahan IR, Knaack D. Donor Age and Gender Effects on Osteoinductivity of Demineralized Bone Matrix. pdf SpinalGraft Technologies, LLC AATB Accreditation (.pdf) 248KB. It can be used with certain Medtronic interbody devices, when hydrated with bone marrow aspirate (BMA) for spinal and orthopedic procedures.

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