This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
Approval for the ray threaded fusion cage (tfc) with instrumentation
| Device | RAY THREADED FUSION CAGE (TFC)(TM) 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 | 1995-06-14 |
| Decision Date | 1996-10-29 |
| Notice Date | 1997-03-03 |
| PMA | P950019 |
| Supplement | S |
| Product Code | MAX |
| Docket Number | 97M-0052 |
| Advisory Committee | Orthopedic |
| Expedited Review | Yes |
| Combination Product | No |
| Applicant Address | STRYKER SPINE 2 Pearl Court allendale, NJ 07401 |
| Approval Order: | Approval Order |
| 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 |