PMA P010014S026
- Device
- OXFORD MENSICAL UNICOMPARTMENTAL KNEE SYSTEM
- Applicant
- Biomet Manufacturing Corp
- PMA number
- P010014
- Supplement
- S026
- Product code
- NRA
- Decision date
- 2010-03-29
- 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 ADDITION OF THE OXFORD PARTIAL KNEE TWIN PEG FEMORALS WHICH INCORPORATE ROUNDED ANTERIOR CORNERS IN COMPARISON TO THE OXFORD KNEE FEMORAL COMPONENT WITH 2 PEGS.
Current openFDA PMA Record#
- Device
- OXFORD MENSICAL UNICOMPARTMENTAL KNEE SYSTEM
- Applicant
- Biomet Manufacturing Corp
- PMA number
- P010014
- Supplement
- S026
- Product code
- NRA
- Generic name
- Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing
- Decision date
- 2010-03-29
- Decision code
- APPR
- Date received
- 2009-12-29
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE ADDITION OF THE OXFORD PARTIAL KNEE TWIN PEG FEMORALS WHICH INCORPORATE ROUNDED ANTERIOR CORNERS IN COMPARISON TO THE OXFORD KNEE FEMORAL COMPONENT WITH 2 PEGS.