BIRMINGHAM HIP RESURFACING (BHR) SYSTEM
FDA premarket approval P040033/S039 · decided 2025-01-10
Approval details
- PMA number
- P040033
- Supplement
- S039
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- BIRMINGHAM HIP RESURFACING (BHR) SYSTEM
- Generic name
- Prosthesis, hip, semi-constrained, metal/metal, resurfacing
- Applicant
- Smith & Nephew, Inc.
- Date received
- 2024-12-12
- Decision date
- 2025-01-10
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- NXT
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Memphis, TN
- Statement
- a change in packaging to add alternative top foam inserts used in the packaging of specified sizes of BIRMINGHAM HIP RESURFACING (BHR) Acetabular Cups and BHR Femoral Head Implants manufactured at Smith & Nephew Orthopaedics Ltd. (SNOL), Leamington Spa, United Kingdom
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