PMA P010014S068
- Device
- Oxford Partial Knee System - Femoral and Tibial Tray Components
- Applicant
- Biomet Manufacturing Corp
- PMA number
- P010014
- Supplement
- S068
- Product code
- NRA
- Decision date
- 2017-12-13
- Classification
- Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-constrained, Metal/polymer, Mobile Bearing
- Generic name
- Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing
- Approval order statement
- Approval for modifications to the instructions for the cosmetic inspection process.
Current openFDA PMA Record#
- Device
- Oxford Partial Knee System - Femoral and Tibial Tray Components
- Applicant
- Biomet Manufacturing Corp
- PMA number
- P010014
- Supplement
- S068
- Product code
- NRA
- Generic name
- Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing
- Decision date
- 2017-12-13
- Decision code
- APPR
- Date received
- 2017-11-16
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for modifications to the instructions for the cosmetic inspection process.