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 to add the 9mm x 20mm bak vista interbody fusion device, which is manufactured from 65% peek optima and 35% toho besfight c6-uh carbon fiber, to the approved product line for the bak interbody fusion system. The device will be marketed under the trade name bak vista interbody fusion device and is indicated for use with autogenous bone graft in patients with degenerative disc disease (ddd) at the l2-s1 levels. These ddd patients may also have up to grade i spondylolisthesis or retrolisthesis at the involved level(s). Bak devices are to be implanted via an open anterior or posterior approach. Ddd is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients would be skeletally mature and have had six months of non-operative treatment.
| Device | BAK VISTA INTERBODY FUSION CAGE |
| Generic Name | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | Zimmer Spine, Inc |
| Date Received | 2003-09-29 |
| Decision Date | 2003-10-31 |
| PMA | P950002 |
| Supplement | S012 |
| 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 |