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.
Removal of the post sterilization inspection for the ray threaded fusion cage with instrumentation.
| Device | RAY THREADED FUSION CAGE(TFC-TM) DEVICE WITH INSTRUMENTATION |
| Classification Name | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Generic Name | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | STRYKER SPINE |
| Date Received | 2000-03-21 |
| Decision Date | 2000-03-30 |
| PMA | P950019 |
| Supplement | S011 |
| Product Code | MAX |
| Advisory Committee | Orthopedic |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| 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 |