OXFORD MENISCAL UNICOMPARTMENTAL KNEE
FDA premarket approval P010014/S009 · decided 2006-07-18
Approval details
- PMA number
- P010014
- Supplement
- S009
- Supplement type
- Special (Immediate Track)
- Trade name
- OXFORD MENISCAL UNICOMPARTMENTAL KNEE
- Generic name
- Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing
- Applicant
- Biomet Manufacturing Corp
- Date received
- 2006-07-03
- Decision date
- 2006-07-18
- Days to decision
- 15 days
- Decision code
- APPR
- Product code
- NRA
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Warsaw, IN
- Statement
- APPROVAL FOR CHANGES TO THE PROCESS SPECIFICATIONS FOR THE 9-STAGE KERRY CLEANING PLANT USED IN THE ULTRASONIC CLEANING OF THE OXFORD MENISCAL UNICOMPARTMENTAL KNEE SYSTEM METALLIC COMPONENTS (FEMORAL AND TIBIAL). THE CHANGES REQUIRE DETAILED MONITORING OF THE ULTRASONIC EQUIPMENT TO ENSURE THE ADEQUACY OF ITS OUTPUT.
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510(k) clearances by this applicant
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|---|---|---|
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| Comprehensive Vault Reconstruction System (K202232) | Biomet Manufacturing Corp | 2021-02-19 |
| Comprehensive Shoulder System (K193038) | Biomet Manufacturing Corp | 2020-10-28 |
| Comprehensive Nano Stemless Shoulder (K182516) | Biomet Manufacturing Corp | 2019-04-22 |
| Comprehensive Reverse Shoulder System (K181611) | Biomet Manufacturing Corp | 2018-09-24 |
| Comprehensive Segmental Revision System (SRS) (K173411) | Biomet Manufacturing Corp | 2018-02-08 |