OXFORD MENISCAL UNICOMPARTMENTAL KNEE SYSTEM
FDA premarket approval P010014/S005 · decided 2007-08-03
Approval details
- PMA number
- P010014
- Supplement
- S005
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Express GMP Supplement
- 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
- 2005-11-01
- Decision date
- 2007-08-03
- Days to decision
- 640 days
- Decision code
- APPR
- Product code
- NRA
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Warsaw, IN
- Statement
- APPROVAL FOR A STERILIZATION SITE LOCATED AT ISOTRON PLC, BERKSHIRE, UNITED KINGDOM.
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