- Device
- OXFORD(TM) MENISCAL UNICOMPARTMENTAL KNEE SYSTEM
- Applicant
- Biomet Manufacturing Corp
- PMA number
- P010014
- Supplement
- S110
- Product code
- NRA
- Generic name
- Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing
- Decision date
- 2025-06-24
- Decision code
- OK30
- Date received
- 2025-05-30
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- the following changes within the Solvac parts washer: an additional modified basket, an increase in immersion time, and use of an additional solvent in the Solvac parts washer for use in the vapor rinse step