SBI BRAUN-CUTTER TRAPEZ-METACARPAL PROSTHESIS
FDA premarket approval P960053/S004 · decided 2007-09-28
Approval details
- PMA number
- P960053
- Supplement
- S004
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SBI BRAUN-CUTTER TRAPEZ-METACARPAL PROSTHESIS
- Generic name
- Prosthesis, finger, constrained, metal/polymer
- Applicant
- Stryker Corporation
- Date received
- 2007-08-24
- Decision date
- 2007-09-28
- Days to decision
- 35 days
- Decision code
- APPR
- Product code
- KWG
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Selzach
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT PROFESSIONAL CONTRACT STERILIZATION, TAUNTON, MASSACHUSETTS.
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