510(k) K201851
EXULT Femoral component trial - Left, EXULT Femoral component trial - Right by
Corentec Co., Ltd.
— Product Code JWH
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 30, 2020
- Date Received
- July 6, 2020
- Clearance Type
- Special
- 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