|
Device | TOTAL TRAPEZIO METACARPAL PROSTHESIS |
Generic Name | Prosthesis, finger, constrained, metal/polymer |
Regulation Number | 888.3220 |
Applicant | STRYKER CORPORATION BOHNACKERWEG 1 SELZACH CH 25 |
PMA Number | P960053 |
Supplement Number | S002 |
Date Received | 04/16/1998 |
Decision Date | 06/04/1998 |
Product Code |
KWG |
Advisory Committee |
Orthopedic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement 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. |