PMA P010014S089
- Device
- Oxford Partial Knee System
- Applicant
- Biomet Manufacturing Corp
- PMA number
- P010014
- Supplement
- S089
- Product code
- NRA
- Decision date
- 2019-07-19
- 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 of a material change from POM-C for provisionals to alternative materials polyphenylsulfone.
Current openFDA PMA Record#
- Device
- Oxford Partial Knee System
- Applicant
- Biomet Manufacturing Corp
- PMA number
- P010014
- Supplement
- S089
- Product code
- NRA
- Generic name
- Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing
- Decision date
- 2019-07-19
- Decision code
- APPR
- Date received
- 2019-04-26
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval of a material change from POM-C for provisionals to alternative materials polyphenylsulfone.