OXFORD PARTIAL KNEE SYSTEM
FDA premarket approval P010014/S029 · decided 2011-05-03
Approval details
- PMA number
- P010014
- Supplement
- S029
- Supplement type
- 135 Review Track For 30-Day Notice
- 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
- 2010-10-26
- Decision date
- 2011-05-03
- Days to decision
- 189 days
- Decision code
- APPR
- Product code
- NRA
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Warsaw, IN
- Statement
- ADDITIONAL MANUFACTURING STEPS FOR THE OXFORD® PARTIAL KNEE TWIN PEG FEMORAL COMPONENTS.
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