PMA P010014S058
- Device
- Oxford Partial Knee System - Bearing Components
- Applicant
- Biomet Manufacturing Corp
- PMA number
- P010014
- Supplement
- S058
- Product code
- NRA
- Decision date
- 2016-11-09
- 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 an additional inspection check for the Oxford Partial Knee Meniscal Bearing packaging. The additional check will require operators to visually inspect for presence of vacuum and that no movement of product should occur within the vacuum-sealed pouch.
Current openFDA PMA Record#
- Device
- Oxford Partial Knee System - Bearing Components
- Applicant
- Biomet Manufacturing Corp
- PMA number
- P010014
- Supplement
- S058
- Product code
- NRA
- Generic name
- Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing
- Decision date
- 2016-11-09
- Decision code
- APPR
- Date received
- 2016-10-11
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for an additional inspection check for the Oxford Partial Knee Meniscal Bearing packaging. The additional check will require operators to visually inspect for presence of vacuum and that no movement of product should occur within the vacuum-sealed pouch.