PMA P010014S016
- Device
- OXFORD MENISCAL UNICOMPARTMENTAL KNEE SYSTEM
- Applicant
- Biomet Manufacturing Corp
- PMA number
- P010014
- Supplement
- S016
- Product code
- NRA
- Decision date
- 2007-09-12
- 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 NEW FIXTURING TO BE USED DURING THE MANUFACTURING OF THE TIBIAL COMPONENTS OF THE OXFORD MENISCAL UNICOMPARTMENTAL KNEE SYSTEM TO PREVENT COMPONENTS BEING MIS-MARKED.
Current openFDA PMA Record#
- Device
- OXFORD MENISCAL UNICOMPARTMENTAL KNEE SYSTEM
- Applicant
- Biomet Manufacturing Corp
- PMA number
- P010014
- Supplement
- S016
- Product code
- NRA
- Generic name
- Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing
- Decision date
- 2007-09-12
- Decision code
- APPR
- Date received
- 2007-08-10
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR NEW FIXTURING TO BE USED DURING THE MANUFACTURING OF THE TIBIAL COMPONENTS OF THE OXFORD MENISCAL UNICOMPARTMENTAL KNEE SYSTEM TO PREVENT COMPONENTS BEING MIS-MARKED.