- Device
- Birmingham Hip Resurfacing (BHR) System
- Applicant
- Smith & Nephew, Inc.
- PMA number
- P040033
- Supplement
- S036
- Product code
- NXT
- Generic name
- Prosthesis, hip, semi-constrained, metal/metal, resurfacing
- Decision date
- 2022-05-19
- Decision code
- OK30
- Date received
- 2022-04-22
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Removal of the x-ray equipment used in the post-irradiation receiving process for the Birmingham Hip Resurfacing System.