PMA P010014S085
- Device
- Oxford Partial Knee System
- Applicant
- Biomet Manufacturing Corp
- PMA number
- P010014
- Supplement
- S085
- Product code
- NRA
- Decision date
- 2019-04-17
- 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
- Introduce Paramelt F30-53 pattern-wax and Paramelt “Zimmer” Sprue Wax into the casting process at Biomet Fair Lawn. This wax is used during the casting process of the metallic femoral and tibial components.
Current openFDA PMA Record#
- Device
- Oxford Partial Knee System
- Applicant
- Biomet Manufacturing Corp
- PMA number
- P010014
- Supplement
- S085
- Product code
- NRA
- Generic name
- Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing
- Decision date
- 2019-04-17
- Decision code
- OK30
- Date received
- 2019-03-18
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Introduce Paramelt F30-53 pattern-wax and Paramelt “Zimmer” Sprue Wax into the casting process at Biomet Fair Lawn. This wax is used during the casting process of the metallic femoral and tibial components.