PMA P010014S018
- Device
- OXFORD PARTIAL KNEE
- Applicant
- Biomet Manufacturing Corp
- PMA number
- P010014
- Supplement
- S018
- Product code
- NRA
- Decision date
- 2008-02-25
- 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 BIOMET FAIR LAWN, L.PL, LOCATED IN FAIR LAWN, NEW JERSEY, TO BE ADDED AS A MATERIAL VENDOR AND CONTRACT MANUFACTURER FOR THE CASTING PROCESS.
Current openFDA PMA Record#
- Device
- OXFORD PARTIAL KNEE
- Applicant
- Biomet Manufacturing Corp
- PMA number
- P010014
- Supplement
- S018
- Product code
- NRA
- Generic name
- Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing
- Decision date
- 2008-02-25
- Decision code
- APPR
- Date received
- 2007-11-20
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR BIOMET FAIR LAWN, L.PL, LOCATED IN FAIR LAWN, NEW JERSEY, TO BE ADDED AS A MATERIAL VENDOR AND CONTRACT MANUFACTURER FOR THE CASTING PROCESS.