BRAUN-CUTTER TRAPEZO-METACARPAL PROSTHESIS
FDA premarket approval P960053/S005 · decided 2016-08-09
Approval details
- PMA number
- P960053
- Supplement
- S005
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- BRAUN-CUTTER TRAPEZO-METACARPAL PROSTHESIS
- Generic name
- Prosthesis, finger, constrained, metal/polymer
- Applicant
- Stryker Corporation
- Date received
- 2016-07-13
- Decision date
- 2016-08-09
- Days to decision
- 27 days
- Decision code
- APPR
- Product code
- KWG
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Selzach
- Statement
- Approval of changes to the device labeling.
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