OXFORD PARTIAL KNEE
FDA premarket approval P010014/S018 · decided 2008-02-25
Approval details
- PMA number
- P010014
- Supplement
- S018
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- OXFORD PARTIAL KNEE
- Generic name
- Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing
- Applicant
- Biomet Manufacturing Corp
- Date received
- 2007-11-20
- Decision date
- 2008-02-25
- Days to decision
- 97 days
- Decision code
- APPR
- Product code
- NRA
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Warsaw, IN
- Statement
- APPROVAL FOR BIOMET FAIR LAWN, L.PL, LOCATED IN FAIR LAWN, NEW JERSEY, TO BE ADDED AS A MATERIAL VENDOR AND CONTRACT MANUFACTURER FOR THE CASTING PROCESS.
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