PMA P010014S067
- Device
- Oxford Partial Knee System - tibial tray and femoral components
- Applicant
- Biomet Manufacturing Corp
- PMA number
- P010014
- Supplement
- S067
- Product code
- NRA
- Decision date
- 2017-10-05
- 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
- Repeat of a specific manufacturing step if needed and allowing that data from erratic sensors not be used to accept or reject a production run provided other sensors co-located with the erratic sensor conform to specification.
Current openFDA PMA Record#
- Device
- Oxford Partial Knee System - tibial tray and femoral components
- Applicant
- Biomet Manufacturing Corp
- PMA number
- P010014
- Supplement
- S067
- Product code
- NRA
- Generic name
- Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing
- Decision date
- 2017-10-05
- Decision code
- OK30
- Date received
- 2017-09-11
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Repeat of a specific manufacturing step if needed and allowing that data from erratic sensors not be used to accept or reject a production run provided other sensors co-located with the erratic sensor conform to specification.