|
Device | BRAUN-CUTTER TRAPEZO-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 | S005 |
Date Received | 07/13/2016 |
Decision Date | 08/09/2016 |
Product Code |
KWG |
Advisory Committee |
Orthopedic |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval of changes to the device labeling. |