EAUM TOTAL KNEE SYSTEM
FDA 510(k) clearance K110404 · decided 2012-02-16
Clearance details
- K-number
- K110404
- Device name
- EAUM TOTAL KNEE SYSTEM
- Applicant
- Corentec Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2011-02-14
- Decision date
- 2012-02-16
- Days to decision
- 367 days
- Clearance type
- Traditional
- Product code
- JWH
- Device class
- 2
- Regulation number
- 888.3560
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| LOSPA Tibial Insert Model/Catalog Number: See below Software Version: N/A Product Descript recall (Z-1934-2024) | CORENTEC CO., LTD | 2024-05-31 |
| LOSPA Patella Component Model/Catalog Number: 01.10.9XX Software Version: N/A Product Desc recall (Z-1935-2024) | CORENTEC CO., LTD | 2024-05-31 |