|
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 | S001 |
Date Received | 03/31/1998 |
Decision Date | 06/04/1998 |
Product Code |
KWG |
Advisory Committee |
Orthopedic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
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. |