This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
Approval for the bak interbody fusion system with instrumentation.
| Device | BAK INTERBODY FUSION SYSTEM |
| Generic Name | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | Zimmer Spine, Inc |
| Date Received | 1995-01-17 |
| Decision Date | 1996-09-20 |
| Notice Date | 1996-11-18 |
| PMA | P950002 |
| Supplement | S |
| Product Code | MAX |
| Docket Number | 96M-0424 |
| Advisory Committee | Orthopedic |
| Expedited Review | Yes |
| Combination Product | No |
| Applicant Address | Zimmer Spine, Inc 7375 Bush Lake Road minneapolis, MN 55439 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P950002 | Original Filing | |
| S014 | 2004-01-21 | Real-time Process |
| S013 | 2003-12-24 | Real-time Process |
| S012 | 2003-09-29 | Real-time Process |
| S011 | 2002-08-29 | Normal 180 Day Track |
| S010 | ||
| S009 | 2001-03-08 | Special (immediate Track) |
| S008 | 1999-10-22 | Real-time Process |
| S007 | 1999-02-11 | Normal 180 Day Track |
| S006 | 1998-01-08 | Normal 180 Day Track |
| S005 | 1997-12-15 | Real-time Process |
| S004 | 1997-06-13 | Real-time Process |
| S003 | 1997-03-19 | Normal 180 Day Track |
| S002 | 1997-02-05 | Real-time Process |
| S001 | 1996-12-26 | Real-time Process |