OXFORD MENISCAL UNICOMPARTMENTAL KNEE SYSTEM
FDA premarket approval P010014/S008 · decided 2006-03-15
Approval details
- PMA number
- P010014
- Supplement
- S008
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- 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
- 2006-02-09
- Decision date
- 2006-03-15
- Days to decision
- 34 days
- Decision code
- APPR
- Product code
- NRA
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Warsaw, IN
- Statement
- APPROVAL FOR A PRODUCT LINE EXTENSION TO INCLUDE A SERIES OF EXTRA-SMALL COMPONENTS (FEMORAL, MENISCAL BEARING, TIBIAL TRAY) AND A NEW SERIES OF ANATOMIC (LEFT AND RIGHT SPECIFIC) MENISCAL BEARING COMPONENTS.
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