PMA P010014S006
- Device
- OXFORD MENISCAL UNICOMPARTMENTAL KNEE SYSTEM
- Applicant
- Biomet Manufacturing Corp
- PMA number
- P010014
- Supplement
- S006
- Product code
- NRA
- Decision date
- 2007-08-30
- Classification
- Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-constrained, Metal/polymer, Mobile Bearing
- Generic name
- Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing
- Approval order statement
- APPROVAL FOR THE FOLLOWING CHANGES IN THE MANUFACTURING PROCESSES FOR THE TIBIAL, MENISCAL BEARING, AND FEMORAL COMPONENTS FOR THE OXFORD MENISCAL UNICOMPARTMENTAL KNEED SYSTEM: 1) ADDITION OF INSPECTION CHECKS; AND 2) ADDITION OF PREWASHES.
Current openFDA PMA Record#
- Device
- OXFORD MENISCAL UNICOMPARTMENTAL KNEE SYSTEM
- Applicant
- Biomet Manufacturing Corp
- PMA number
- P010014
- Supplement
- S006
- Product code
- NRA
- Generic name
- Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing
- Decision date
- 2007-08-30
- Decision code
- APPR
- Date received
- 2005-11-02
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR THE FOLLOWING CHANGES IN THE MANUFACTURING PROCESSES FOR THE TIBIAL, MENISCAL BEARING, AND FEMORAL COMPONENTS FOR THE OXFORD MENISCAL UNICOMPARTMENTAL KNEED SYSTEM: 1) ADDITION OF INSPECTION CHECKS; AND 2) ADDITION OF PREWASHES.