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.
Modified indications for use for the ray tfc and unite threaded fusion cage with instrumentation. These devices are indicated for use with autogenous bone grafts in patients with degenerative disc disease (ddd) at one or two levels for l2 to s1.
| Device | RAY TFC DEVICE AND RAY TFC UNITE DEVICE |
| Classification Name | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Generic Name | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | STRYKER SPINE |
| Date Received | 1999-05-03 |
| Decision Date | 2000-03-02 |
| PMA | P950019 |
| Supplement | S009 |
| Product Code | MAX |
| Docket Number | 00M-1212 |
| Advisory Committee | Orthopedic |
| Supplement Type | Panel Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | STRYKER SPINE 2 Pearl Court allendale, NJ 07401 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| 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 |