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 the addition of the following sizes to the bak product line: a) bak implants (minor diameter (mm) x length (mm)) 11x20, 11x24, 11x28, 11x32, 11x36; 13x24, 13x28, 13x32, 13x36, 13x40; 15x28, 15x32, 15x36, 15x40, 15x44; 17x20, 17x32, 17x36, 17x40, 17x44; 19x24, 19x28, 19x32, 19x36, 19x40, 19x44; 21x28, 21x32, 21x36, 21x40, 21x44; and (b) end caps (diameter (mm)) 11; 19; and 21.
| Device | BAK INTERBODY FUSION SYSTEM |
| Generic Name | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | Zimmer Spine, Inc |
| Date Received | 1997-02-05 |
| Decision Date | 1997-05-09 |
| PMA | P950002 |
| Supplement | S002 |
| 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 |