OXFORD PARTIAL KNEE
FDA premarket approval P010014/S044 · decided 2013-07-30
Approval details
- PMA number
- P010014
- Supplement
- S044
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- OXFORD PARTIAL KNEE
- Generic name
- Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing
- Applicant
- Biomet Manufacturing Corp
- Date received
- 2013-07-12
- Decision date
- 2013-07-30
- Days to decision
- 18 days
- Decision code
- APPR
- Product code
- NRA
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Warsaw, IN
- Statement
- APPROVAL FOR CHANGES TO THE SURGICAL TECHNIQUE MANUAL.
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