TOTAL TRAPEZIO METACARPAL PROSTHESIS
FDA premarket approval P960053/S001 · decided 1998-06-04
Approval details
- PMA number
- P960053
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- TOTAL TRAPEZIO METACARPAL PROSTHESIS
- Generic name
- Prosthesis, finger, constrained, metal/polymer
- Applicant
- Stryker Corporation
- Date received
- 1998-03-31
- Decision date
- 1998-06-04
- Days to decision
- 65 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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