TOTAL TRAPEZIO METACARPAL PROSTHESIS
FDA premarket approval P960053/S002 · decided 1998-06-04
Approval details
- PMA number
- P960053
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- TOTAL TRAPEZIO METACARPAL PROSTHESIS
- Generic name
- Prosthesis, finger, constrained, metal/polymer
- Applicant
- Stryker Corporation
- Date received
- 1998-04-16
- Decision date
- 1998-06-04
- Days to decision
- 49 days
- Decision code
- APPR
- Product code
- KWG
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Selzach
- 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.
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