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 new manufacturing facilities for the ray tfc unite product line. The facilities are located at centerpulse spine-tech, minneapolis, minnesota and biotest laboratories, inc. , minneapolis, minnesota.
| Device | RAY TFC UNITE PRODUCT LINE |
| Classification Name | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Generic Name | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | STRYKER SPINE |
| Date Received | 2003-02-13 |
| Decision Date | 2003-07-15 |
| PMA | P950019 |
| Supplement | S013 |
| Product Code | MAX |
| Advisory Committee | Orthopedic |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Express Gmp Supplement |
| 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 |