Oxford Partial Knee System - Bearing Components
FDA premarket approval P010014/S058 · decided 2016-11-09
Approval details
- PMA number
- P010014
- Supplement
- S058
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Oxford Partial Knee System - Bearing Components
- Generic name
- Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing
- Applicant
- Biomet Manufacturing Corp
- Date received
- 2016-10-11
- Decision date
- 2016-11-09
- Days to decision
- 29 days
- Decision code
- APPR
- Product code
- NRA
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Warsaw, IN
- 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.
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