Oxford Partial Knee System
FDA premarket approval P010014/S072 · decided 2018-04-13
Approval details
- PMA number
- P010014
- Supplement
- S072
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Oxford Partial Knee System
- Generic name
- Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing
- Applicant
- Biomet Manufacturing Corp
- Date received
- 2018-03-14
- Decision date
- 2018-04-13
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- NRA
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Warsaw, IN
- Statement
- Upgrade the water systems used at Biomet. Water is used during the manufacturing and final cleaning processes for Oxford Partial Knee Components.
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| Comprehensive Reverse Shoulder System (K181611) | Biomet Manufacturing Corp | 2018-09-24 |
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