BRAUN-CUTTER TRAPEZO-METACARPAL PROSTHESIS
FDA premarket approval P960053 · decided 1997-06-19
Approval details
- PMA number
- P960053
- Trade name
- BRAUN-CUTTER TRAPEZO-METACARPAL PROSTHESIS
- Generic name
- Prosthesis, finger, constrained, metal/polymer
- Applicant
- Stryker Corporation
- Date received
- 1996-12-24
- Decision date
- 1997-06-19
- Days to decision
- 177 days
- Decision code
- APPR
- Product code
- KWG
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Selzach
- Statement
- APPROVAL FOR THE AVANTA BRAUN-CUTTER TRAPEZO-METACARPAL PROSTHESIS. THIS DEVICE IS INDICATED FOR TOTAL JOINT REPLACEMENT IN SKELETALLY MATURE PATIENTS WITH PAIN OR INSTABILITY OF THE TRAPEZO-METACARPAL JOINT DUE TO TRAUMA, INFLAMMATORY OR DEGENERATIVE DISEASE OR REVISION OF PREVIOUS PROCEDURES, AS AN ALTERNATIVE TO ARTHRODESIS OR RECONSTRUCTIVE SURGERY.
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