PMA P010014S062
- Device
- Oxford Partial Knee System- Meniscal bearings
- Applicant
- Biomet Manufacturing Corp
- PMA number
- P010014
- Supplement
- S062
- Product code
- NRA
- Decision date
- 2017-05-16
- 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
- Harmonize device cleanliness testing methods and parameters across the global organization and change of location of residual testing.
Current openFDA PMA Record#
- Device
- Oxford Partial Knee System- Meniscal bearings
- Applicant
- Biomet Manufacturing Corp
- PMA number
- P010014
- Supplement
- S062
- Product code
- NRA
- Generic name
- Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing
- Decision date
- 2017-05-16
- Decision code
- OK30
- Date received
- 2017-05-05
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Harmonize device cleanliness testing methods and parameters across the global organization and change of location of residual testing.