OXFORD PARTIAL KNEE SYSTEM-TIBIAL TRAYS
FDA premarket approval P010014/S041 · decided 2013-02-14
Approval details
- PMA number
- P010014
- Supplement
- S041
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- OXFORD PARTIAL KNEE SYSTEM-TIBIAL TRAYS
- Generic name
- Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing
- Applicant
- Biomet Manufacturing Corp
- Date received
- 2013-01-03
- Decision date
- 2013-02-14
- Days to decision
- 42 days
- Decision code
- APPR
- Product code
- NRA
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Warsaw, IN
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT BIOMET, INC., IN WARSAW, INDIANA.
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