PMA P010014S076
- Device
- Oxford Partial Knee System
- Applicant
- Biomet Manufacturing Corp
- PMA number
- P010014
- Supplement
- S076
- Product code
- NRA
- Decision date
- 2018-11-20
- 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 the addition of more frequent cleaning intervals, introduction of new sterilants and test strips, and an new deep clean quarterly step.
Current openFDA PMA Record#
- Device
- Oxford Partial Knee System
- Applicant
- Biomet Manufacturing Corp
- PMA number
- P010014
- Supplement
- S076
- Product code
- NRA
- Generic name
- Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing
- Decision date
- 2018-11-20
- Decision code
- APPR
- Date received
- 2018-04-27
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for the addition of more frequent cleaning intervals, introduction of new sterilants and test strips, and an new deep clean quarterly step.