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 1) packaging the implant in a single box containing both the proximal and distal components and changing package labels accordingly, and 2) changing the color of stock used for printing box labels.
| Device | TOTAL TRAPEZIO METACARPAL PROSTHESIS |
| Generic Name | Prosthesis, Finger, Constrained, Metal/polymer |
| Applicant | STRYKER CORPORATION |
| Date Received | 1998-04-16 |
| Decision Date | 1998-06-04 |
| PMA | P960053 |
| Supplement | S002 |
| Product Code | KWG |
| Advisory Committee | Orthopedic |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | STRYKER CORPORATION bohnackerweg 1 selzach CH 25 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P960053 | Original Filing | |
| S005 | 2016-07-13 | Special (immediate Track) |
| S004 | 2007-08-24 | Normal 180 Day Track No User Fee |
| S003 | 2002-11-08 | Normal 180 Day Track |
| S002 | 1998-04-16 | Normal 180 Day Track |
| S001 | 1998-03-31 | Normal 180 Day Track |