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 for a change to the labeling of the bak interbody fusion system adding a precaution statement (ie. , the bak/proximity device is to be used only in conjunctino with a standard bak device. The safety and effectiveness of the bak/proximity device has not been established when used otherwise. ) effective april 1, 2001.
| Device | BAK/PROXIMITY(TM) INTERBODY FUSION SYSTEM |
| Generic Name | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | Zimmer Spine, Inc |
| Date Received | 2001-03-08 |
| Decision Date | 2001-04-03 |
| PMA | P950002 |
| Supplement | S009 |
| Product Code | MAX |
| Advisory Committee | Orthopedic |
| Supplement Type | Special (immediate Track) |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| 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 |