Oxford Partial Knee System- Meniscal bearings
FDA premarket approval P010014/S062 · decided 2017-05-16
Approval details
- PMA number
- P010014
- Supplement
- S062
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Oxford Partial Knee System- Meniscal bearings
- Generic name
- Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing
- Applicant
- Biomet Manufacturing Corp
- Date received
- 2017-05-05
- Decision date
- 2017-05-16
- Days to decision
- 11 days
- Decision code
- OK30
- Product code
- NRA
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Warsaw, IN
- Statement
- Harmonize device cleanliness testing methods and parameters across the global organization and change of location of residual testing.
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