Osteotech Inc
FDA Regulatory Profile
Osteotech Inc appears in FDA public data with 12 recalls, 24 510(k) clearances, 11 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0088-2013, Class II) was initiated on April 20, 2012. Its most recent 510(k) clearance was granted on October 16, 2008.
Summary
- Total Recalls
- 12
- 510(k) Clearances
- 24
- Inspections
- 11
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0088-2013 | Class II | Grafton DBM Matrix PLF Multiple Sizes Grafton is a human bone allograft product containing demin | April 20, 2012 |
| Z-0085-2013 | Class II | Grafton DBM Flex Multiple Sizes Grafton is a human bone allograft product containing demineraliz | April 20, 2012 |
| Z-0086-2013 | Class II | Grafton DBM A-Flex Multiple Sizes Grafton is a human bone allograft product containing demineral | April 20, 2012 |
| Z-0087-2013 | Class II | Grafton DBM Crunch Multiple Sizes Grafton is a human bone allograft product containing demineral | April 20, 2012 |
| Z-0094-2013 | Class II | Optimum Expanse S Multiple sizes Grafton is a human bone allograft product containing deminerali | April 20, 2012 |
| Z-0083-2013 | Class II | Grafton DBM Putty Multiple Sizes Grafton is a human bone allograft product containing deminerali | April 20, 2012 |
| Z-0084-2013 | Class II | Grafton DBM Gel Multiple Sizes Grafton is a human bone allograft product containing demineralize | April 20, 2012 |
| Z-0090-2013 | Class II | Grafton DBM Orthoblend Small Defect Multiple Sizes Grafton is a human bone allograft product con | April 20, 2012 |
| Z-0091-2013 | Class II | Grafton DBM Orthoblend Large Defect Multiple Sizes Grafton is a human bone allograft product co | April 20, 2012 |
| Z-0092-2013 | Class II | Grafton DBM Orthoblend Large Defect Multiple Sizes Grafton is a human bone allograft product co | April 20, 2012 |
| Z-0089-2013 | Class II | Grafton DBM Matrix Strips Multiple Sizes Grafton is a human bone allograft product containing de | April 20, 2012 |
| Z-0093-2013 | Class II | Optimum Expanse R Grafton is a human bone allograft product containing demineralized human bone t | April 20, 2012 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K082615 | GRAFTON R II EDBM, DEMINERALIZED BONE MATRIX ALLOGRAFT, RESORBABLE CALCIUM SALT BONE VOID FILLER DEV | October 16, 2008 |
| K081227 | PLEXUR M | July 22, 2008 |
| K080511 | PLEXUR-P | April 21, 2008 |
| K073405 | PLEXUR M | March 3, 2008 |
| K061982 | PLEXUR P | February 7, 2007 |
| K051188 | GRAFTON DBM | January 3, 2006 |
| K051195 | GRAFTON DBM | December 16, 2005 |
| K051781 | GRAFTCAGE TLX | December 16, 2005 |
| K043209 | VIAGRAF DBM PASTE | December 5, 2005 |
| K053080 | GRAFTCAGE ACX | December 1, 2005 |
| K042707 | GRAFTON PLUS DBM PASTE | November 30, 2005 |
| K043048 | GRAFTON PLUS DBM PASTE | November 23, 2005 |
| K012254 | VBR | October 16, 2001 |
| K003155 | VERTEBRAL BODY REPLACEMENT | January 4, 2001 |
| K003384 | VERSALINK TITANIUM ROD-TO-ROD COUPLERS | November 24, 2000 |
| K992885 | VERSALOK LOW BACK FIXATION SYSTEM | November 19, 1999 |
| K991586 | SSCS (SEGMENTAL SPINAL CORRECTION SYSTEM) | July 23, 1999 |
| K973868 | SSCS (SEGMENTAL SPINAL CORRECTION SYSTEM) | January 8, 1998 |
| K971289 | SSCS (SEGMENTAL SPINAL CORRECTION SYSTEM) | June 18, 1997 |
| K955173 | SSCS (SEGMENTAL SPINAL CORRECTION SYSTEM) | February 9, 1996 |