PMA P010014S092
- Device
- Oxford Partial Knee System
- Applicant
- Biomet Manufacturing Corp
- PMA number
- P010014
- Supplement
- S092
- Product code
- NRA
- Decision date
- 2019-09-12
- 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
- Add an in-process ultrasonic clean system and upgrade to the sensitivity level of the penetrant dye to increase penetrant inspection sensitivity for the casting process at the Fair Lawn facility.
Current openFDA PMA Record#
- Device
- Oxford Partial Knee System
- Applicant
- Biomet Manufacturing Corp
- PMA number
- P010014
- Supplement
- S092
- Product code
- NRA
- Generic name
- Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing
- Decision date
- 2019-09-12
- Decision code
- OK30
- Date received
- 2019-08-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Add an in-process ultrasonic clean system and upgrade to the sensitivity level of the penetrant dye to increase penetrant inspection sensitivity for the casting process at the Fair Lawn facility.