Osteotech Inc
Eatontown, NJ, US
OSTEOTECH, INC. appears in FDA device records in Eatontown, NJ. FDA records list 24 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 14 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 24 510(k) clearances for Osteotech Inc between 1985 and 2008. The busiest year on record is 2005, with 6. The most recent is 2008, with 4.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1985 | 1 |
| 1988 | 1 |
| 1995 | 2 |
| 1996 | 1 |
| 1997 | 1 |
| 1998 | 1 |
| 1999 | 2 |
| 2000 | 1 |
| 2001 | 2 |
| 2005 | 6 |
| 2006 | 1 |
| 2007 | 1 |
| 2008 | 4 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K082615 | GRAFTON R II EDBM, DEMINERALIZED BONE MATRIX ALLOGRAFT, RESORBABLE CALCIUM SALT BONE VOID FILLER DEVICES | MQV | Substantially Equivalent | |
| K081227 | PLEXUR M | MQV | Substantially Equivalent | |
| K080511 | PLEXUR-P | MQV | Substantially Equivalent | |
| K073405 | PLEXUR M | MQV | Substantially Equivalent | |
| K061982 | PLEXUR P | MBP | Substantially Equivalent | |
| K051188 | GRAFTON DBM | NUN | Substantially Equivalent | |
| K051781 | GRAFTCAGE TLX | MQP | Substantially Equivalent | |
| K051195 | GRAFTON DBM | MBP | Substantially Equivalent | |
| K043209 | VIAGRAF DBM PASTE | MBP | Substantially Equivalent | |
| K053080 | GRAFTCAGE ACX | MQP | Substantially Equivalent | |
| K042707 | GRAFTON PLUS DBM PASTE | NUN | Substantially Equivalent | |
| K043048 | GRAFTON PLUS DBM PASTE | MBP | Substantially Equivalent | |
| K012254 | VBR | MQP | Substantially Equivalent | |
| K003155 | VERTEBRAL BODY REPLACEMENT | MQP | Substantially Equivalent | |
| K003384 | VERSALINK TITANIUM ROD-TO-ROD COUPLERS | MNH | Substantially Equivalent | |
| K992885 | VERSALOK LOW BACK FIXATION SYSTEM | KWP | Substantially Equivalent | |
| K991586 | SSCS (SEGMENTAL SPINAL CORRECTION SYSTEM) | KWP | Substantially Equivalent | |
| K973868 | SSCS (SEGMENTAL SPINAL CORRECTION SYSTEM) | KWP | Substantially Equivalent for Some Indications | |
| K971289 | SSCS (SEGMENTAL SPINAL CORRECTION SYSTEM) | KWP | Substantially Equivalent | |
| K955173 | SSCS (SEGMENTAL SPINAL CORRECTION SYSTEM) | KWP | Substantially Equivalent for Some Indications | |
| K950652 | OSTEOTECH NAVICULAR AND CANCELLOUS CANNULATED SCREWS | HWC | Substantially Equivalent for Some Indications | |
| K951811 | OSTEOTECH MUSCULOSKELETAL TISSUE RECOVERY PACK | LRP | Substantially Equivalent | |
| K883065 | ALLOPREP SYSTEM | KIT | Substantially Equivalent | |
| K852199 | OSTEOGRAF 2040 OSTEOGRAF 4060 | LYC | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2249915 | 3002600221 | OSTEOTECH, INC. | 201 Industrial Way West, EATONTOWN, NJ 07724 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KWPAppliance, Fixation, Spinal Interlaminal
- NUNBone Grafting Material, Human Source
- LYCBone Grafting Material, Synthetic
- MQVFiller, Bone Void, Calcium Compound
- MBPFiller, Bone Void, Osteoinduction (W/O Human Growth Factor)
- KITMedia And Components, Synthetic Cell And Tissue Culture
- MNHOrthosis, Spondylolisthesis Spinal Fixation
- HWCScrew, Fixation, Bone
- MQPSpinal Vertebral Body Replacement Device
- FMFSyringe, Piston
- LRPTray, Surgical
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0094-2013 | Optimum Expanse S Multiple sizes Grafton is a human bone allograft product containing demineralized human bone tissue combined with inert additive to yield a demineralized bone matrix (DBM) allograft. It is 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. The voids or gaps may be surgically created defects or effects created by traumatic injury to the bone. | Multiple lots of GRAFTON and XPANSE , which are used for bone grafting procedures are being recalled because there is a possibility that sterility of the outer surface of the inner pouch may become compromised. | Class II | Terminated | |
| Z-0093-2013 | Optimum Expanse R Grafton is a human bone allograft product containing demineralized human bone tissue combined with inert additive to yield a demineralized bone matrix (DBM) allograft. It is intended for use as a bone graft extender, bone graft substitute and bone void filler in bony voids or gaps of the skeletal system (ie spine, pelvis and extremeties) not intrinsic to the stability of the bony structure. The voids or gaps may be surgically created defects or effects created by traumatic injury to the bone. | Multiple lots of GRAFTON and XPANSE , which are used for bone grafting procedures are being recalled because there is a possibility that sterility of the outer surface of the inner pouch may become compromised. | Class II | Terminated | |
| Z-0092-2013 | Grafton DBM Orthoblend Large Defect Multiple Sizes Grafton is a human bone allograft product containing demineralized human bone tissue combined with inert additive to yield a demineralized bone matrix (DBM) allograft. It is intended for use as a bone graft extender, bone graft substitute and bone void filler in bony voids or gaps of the skeletal system (ie spine, pelvis and extremeties) not intrinsic to the stability of the bony structure. The voids or gaps may be surgically created defects or effects created by traumatic injury to the bone. | Multiple lots of GRAFTON and XPANSE , which are used for bone grafting procedures are being recalled because there is a possibility that sterility of the outer surface of the inner pouch may become compromised. | Class II | Terminated | |
| Z-0091-2013 | Grafton DBM Orthoblend Large Defect Multiple Sizes Grafton is a human bone allograft product containing demineralized human bone tissue combined with inert additive to yield a demineralized bone matrix (DBM) allograft. It is intended for use as a bone graft extender, bone graft substitute and bone void filler in bony voids or gaps of the skeletal system (ie spine, pelvis and extremeties) not intrinsic to the stability of the bony structure. The voids or gaps may be surgically created defects or effects created by traumatic injury to the bone. | Multiple lots of GRAFTON and XPANSE , which are used for bone grafting procedures are being recalled because there is a possibility that sterility of the outer surface of the inner pouch may become compromised. | Class II | Terminated | |
| Z-0090-2013 | Grafton DBM Orthoblend Small Defect Multiple Sizes Grafton is a human bone allograft product containing demineralized human bone tissue combined with inert additive to yield a demineralized bone matrix (DBM) allograft. It is intended for use as a bone graft extender, bone graft substitute and bone void filler in bony voids or gaps of the skeletal system (ie spine, pelvis and extremeties) not intrinsic to the stability of the bony structure. The voids or gaps may be surgically created defects or effects created by traumatic injury to the bone. | Multiple lots of GRAFTON and XPANSE , which are used for bone grafting procedures are being recalled because there is a possibility that sterility of the outer surface of the inner pouch may become compromised. | Class II | Terminated | |
| Z-0089-2013 | Grafton DBM Matrix Strips Multiple Sizes Grafton is a human bone allograft product containing demineralized human bone tissue combined with inert additive to yield a demineralized bone matrix (DBM) allograft. It is intended for use as a bone graft extender, bone graft substitute and bone void filler in bony voids or gaps of the skeletal system (ie spine, pelvis and extremeties) not intrinsic to the stability of the bony structure. The voids or gaps may be surgically created defects or effects created by traumatic injury to the bone. | Multiple lots of GRAFTON and XPANSE , which are used for bone grafting procedures are being recalled because there is a possibility that sterility of the outer surface of the inner pouch may become compromised. | Class II | Terminated | |
| Z-0088-2013 | Grafton DBM Matrix PLF Multiple Sizes Grafton is a human bone allograft product containing demineralized human bone tissue combined with inert additive to yield a demineralized bone matrix (DBM) allograft. It is intended for use as a bone graft extender, bone graft substitute and bone void filler in bony voids or gaps of the skeletal system (ie spine, pelvis and extremeties) not intrinsic to the stability of the bony structure. The voids or gaps may be surgically created defects or effects created by traumatic injury to the bone. | Multiple lots of GRAFTON and XPANSE , which are used for bone grafting procedures are being recalled because there is a possibility that sterility of the outer surface of the inner pouch may become compromised. | Class II | Terminated | |
| Z-0087-2013 | Grafton DBM Crunch Multiple Sizes Grafton is a human bone allograft product containing demineralized human bone tissue combined with inert additive to yield a demineralized bone matrix (DBM) allograft. It is intended for use as a bone graft extender, bone graft substitute and bone void filler in bony voids or gaps of the skeletal system (ie spine, pelvis and extremeties) not intrinsic to the stability of the bony structure. The voids or gaps may be surgically created defects or effects created by traumatic injury to the bone. | Multiple lots of GRAFTON and XPANSE , which are used for bone grafting procedures are being recalled because there is a possibility that sterility of the outer surface of the inner pouch may become compromised. | Class II | Terminated | |
| Z-0086-2013 | Grafton DBM A-Flex Multiple Sizes Grafton is a human bone allograft product containing demineralized human bone tissue combined with inert additive to yield a demineralized bone matrix (DBM) allograft. It is intended for use as a bone graft extender, bone graft substitute and bone void filler in bony voids or gaps of the skeletal system (ie spine, pelvis and extremeties) not intrinsic to the stability of the bony structure. The voids or gaps may be surgically created defects or effects created by traumatic injury to the bone. | Multiple lots of GRAFTON and XPANSE , which are used for bone grafting procedures are being recalled because there is a possibility that sterility of the outer surface of the inner pouch may become compromised. | Class II | Terminated | |
| Z-0085-2013 | Grafton DBM Flex Multiple Sizes Grafton is a human bone allograft product containing demineralized human bone tissue combined with inert additive to yield a demineralized bone matrix (DBM) allograft. It is intended for use as a bone graft extender, bone graft substitute and bone void filler in bony voids or gaps of the skeletal system (ie spine, pelvis and extremeties) not intrinsic to the stability of the bony structure. The voids or gaps may be surgically created defects or effects created by traumatic injury to the bone. | Multiple lots of GRAFTON and XPANSE , which are used for bone grafting procedures are being recalled because there is a possibility that sterility of the outer surface of the inner pouch may become compromised. | Class II | Terminated | |
| Z-0084-2013 | Grafton DBM Gel Multiple Sizes Grafton is a human bone allograft product containing demineralized human bone tissue combined with inert additive to yield a demineralized bone matrix (DBM) allograft. It is intended for use as a bone graft extender, bone graft substitute and bone void filler in bony voids or gaps of the skeletal system (ie spine, pelvis and extremeties) not intrinsic to the stability of the bony structure. The voids or gaps may be surgically created defects or effects created by traumatic injury to the bone. | Multiple lots of GRAFTON and XPANSE , which are used for bone grafting procedures are being recalled because there is a possibility that sterility of the outer surface of the inner pouch may become compromised. | Class II | Terminated | |
| Z-0083-2013 | Grafton DBM Putty Multiple Sizes Grafton is a human bone allograft product containing demineralized human bone tissue combined with inert additive to yield a demineralized bone matrix (DBM) allograft. It is intended for use as a bone graft extender, bone graft substitute and bone void filler in bony voids or gaps of the skeletal system (ie spine, pelvis and extremeties) not intrinsic to the stability of the bony structure. The voids or gaps may be surgically created defects or effects created by traumatic injury to the bone. | Multiple lots of GRAFTON and XPANSE , which are used for bone grafting procedures are being recalled because there is a possibility that sterility of the outer surface of the inner pouch may become compromised. | Class II | Terminated | |
| Z-0416-2012 | Grafton DBM A-Flex; Unit Size 60 mm diam; 1ea Container: Foil Pouch with Tyvek pouch Fracture repair, bridge bone gaps or fragments, use with strut grafts | Aseptic conditions during the production of these products may have been compromised. | Terminated | ||
| Z-0415-2012 | Grafton DBM Flex; Unit Size 5x5 cm; 1ea Container: Foil Pouch with Tyvek pouch Fracture repair, bridge bone gaps or fragments, use with strut grafts | Aseptic conditions during the production of these products may have been compromised. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain