510(k) K183596
Klassic Knee System - Klassic Knee PS-Post Femur; Klassic Knee Tibial Insert, PS-Post, Std Poly; Klassic Knee Tibial Insert, PS-Post, E-Link Poly by
Total Joint Orthopedics, Inc.
— Product Code JWH
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 29, 2019
- Date Received
- December 21, 2018
- 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