- Device
- BIRMINGHAM HIP™ RESURFACING (BHR) SYSTEM
- Applicant
- Smith & Nephew, Inc.
- PMA number
- P040033
- Supplement
- S039
- Product code
- NXT
- Generic name
- Prosthesis, hip, semi-constrained, metal/metal, resurfacing
- Decision date
- 2025-01-10
- Decision code
- OK30
- Date received
- 2024-12-12
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order 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