Oxford Partial Knee System
FDA premarket approval P010014/S056 · decided 2016-10-21
Approval details
- PMA number
- P010014
- Supplement
- S056
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Oxford Partial Knee System
- Generic name
- Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing
- Applicant
- Biomet Manufacturing Corp
- Date received
- 2016-09-21
- Decision date
- 2016-10-21
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- NRA
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Warsaw, IN
- 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.
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