OXFORD MENISCAL UNICOMPARTMENTAL KNEE SYSTEM
FDA premarket approval P010014/S001 · decided 2006-03-23
Approval details
- PMA number
- P010014
- Supplement
- S001
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- OXFORD MENISCAL UNICOMPARTMENTAL KNEE SYSTEM
- Generic name
- Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing
- Applicant
- Biomet Manufacturing Corp
- Date received
- 2004-06-04
- Decision date
- 2006-03-23
- Days to decision
- 657 days
- Decision code
- APPR
- Product code
- NRA
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Warsaw, IN
- Statement
- APPROVAL OF THE POST-APPROVAL STUDY FOR THE DEVICE.
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