PMA P010014S056
- Device
- Oxford Partial Knee System
- Applicant
- Biomet Manufacturing Corp
- PMA number
- P010014
- Supplement
- S056
- Product code
- NRA
- Decision date
- 2016-10-21
- 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 to update the instructions provided on preoperative size selection of the femoral component and its cementing technique, within the approved surgical technique for the Oxford Partial Knee System.
Current openFDA PMA Record#
- Device
- Oxford Partial Knee System
- Applicant
- Biomet Manufacturing Corp
- PMA number
- P010014
- Supplement
- S056
- Product code
- NRA
- Generic name
- Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing
- Decision date
- 2016-10-21
- Decision code
- APPR
- Date received
- 2016-09-21
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval to update the instructions provided on preoperative size selection of the femoral component and its cementing technique, within the approved surgical technique for the Oxford Partial Knee System.