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 the addition of 20mm cages and modified labeling.
| Device | RAY TFC DEVICE WITH INSTRUMENTATION (20MM) |
| Classification Name | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Generic Name | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | STRYKER SPINE |
| Date Received | 1998-05-15 |
| Decision Date | 1998-06-17 |
| PMA | P950019 |
| Supplement | S003 |
| Product Code | MAX |
| Advisory Committee | Orthopedic |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | STRYKER SPINE 2 Pearl Court allendale, NJ 07401 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P950019 | Original Filing | |
| S016 | 2003-09-26 | Special (immediate Track) |
| S015 | 2003-07-28 | Special (immediate Track) |
| S014 | 2003-02-13 | Normal 180 Day Track No User Fee |
| S013 | 2003-02-13 | Normal 180 Day Track No User Fee |
| S012 | 2002-02-11 | Real-time Process |
| S011 | 2000-03-21 | 30-day Notice |
| S010 | 1999-09-27 | Normal 180 Day Track |
| S009 | 1999-05-03 | Panel Track |
| S008 | 1999-04-20 | Normal 180 Day Track |
| S007 | 1999-02-18 | Real-time Process |
| S006 | 1999-01-20 | Real-time Process |
| S005 | 1998-10-20 | Real-time Process |
| S004 | 1998-08-18 | Real-time Process |
| S003 | 1998-05-15 | Normal 180 Day Track |
| S002 | 1998-05-08 | Real-time Process |
| S001 | 1997-03-18 | Normal 180 Day Track |