This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
Approval of design changes to the insertion end of the polyethylene endcap and the insertion tools used as part of the bak interbody fusion system.
| Device | BAK INTERBODY FUSION SYSTEM |
| Generic Name | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | Zimmer Spine, Inc |
| Date Received | 1997-06-13 |
| Decision Date | 1997-06-30 |
| PMA | P950002 |
| Supplement | S004 |
| Product Code | MAX |
| Advisory Committee | Orthopedic |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Zimmer Spine, Inc 7375 Bush Lake Road minneapolis, MN 55439 |
| 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 |