510(k) K110404
K110404 is an FDA 510(k) premarket notification submitted by Corentec Co., Ltd. for the device "EAUM TOTAL KNEE SYSTEM". The FDA issued a decision of Substantially Equivalent on Feb 16, 2012. The device falls under product code JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer), a Class II device regulated under 21 CFR 888.3560. Corentec Co., Ltd. has 32 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 16, 2012
- Date Received
- Feb 14, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- Device Class
- Class II
- Regulation Number
- 888.3560
- Review Panel
- OR
- Submission Type
- 510(k)