OXFORD MENISCAL UNICOMPARTMENTAL KNEE SYSTEM
FDA premarket approval P010014/S015 · decided 2007-07-05
Approval details
- PMA number
- P010014
- Supplement
- S015
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- 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
- 2007-02-27
- Decision date
- 2007-07-05
- Days to decision
- 128 days
- Decision code
- APPR
- Product code
- NRA
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Warsaw, IN
- Statement
- APPROVAL FOR CHANGES TO THE PROCESS SPECIFICATIONS FOR THE AQUEOUS CLEANING PROCESS USED DURING THE MANUFACTURE OF THE COMPONENTS OF BIOMET?S OXFORD MENISCAL UNICOMPARTMENTAL KNEE SYSTEM.
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