- Device
- Oxford Partial Knee System
- Applicant
- Biomet Manufacturing Corp
- PMA number
- P010014
- Supplement
- S108
- Product code
- NRA
- Generic name
- Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing
- Decision date
- 2024-11-18
- Decision code
- OK30
- Date received
- 2024-10-24
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to transfer the testing for packaging process monitoring from Biomet Inc. to ATS Labs, Zimmer Inc., Warsaw, for the Oxford Partial Knee tibial trays, twin peg femoral components and meniscal bearings, manufactured at Biomet Inc