OXFORD PARTIAL KNEE
FDA premarket approval P010014/S031 · decided 2011-07-29
Approval details
- PMA number
- P010014
- Supplement
- S031
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- OXFORD PARTIAL KNEE
- Generic name
- Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing
- Applicant
- Biomet Manufacturing Corp
- Date received
- 2011-05-31
- Decision date
- 2011-07-29
- Days to decision
- 59 days
- Decision code
- APPR
- Product code
- NRA
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Warsaw, IN
- Statement
- APPROVAL FOR LABELING CHANGES TO THE SURGICAL TECHNIQUE BROCHURE FOR THE OXFORD PARTIAL KNEE SYSTEM THAT INCLUDE THE ADDITION OF INSTRUCTIONS FOR USE FOR THE SIGNATURE PERSONALIZED PATIENT CARE SYSTEM (PATIENT-MATCHED CUTTING/DRILLING GUIDES.)
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