Birmingham Hip Resurfacing (BHR) System
FDA premarket approval P040033/S037 · decided 2023-02-22
Approval details
- PMA number
- P040033
- Supplement
- S037
- 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
- 2023-01-26
- Decision date
- 2023-02-22
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- NXT
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Memphis, TN
- Statement
- Addition of a more time-efficient laser maker to the laser marking process for the Birmingham Hip Resurfacing System including moving the laser marking operation earlier in the manufacturing process flow.
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