Smith & Nephew, Inc. · Class II · Cleared May 4, 2023
| K-number | K230653 |
| Device name | Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and II Knee Systems, JOURNEY II CR Knee System, JOURNEY II Uni Knee System, Journey II UK Knee System, JOURNEY II XR Bi-Cruciate Retaining Knee System, JOURNEY PFJ System, JOURNEY Uni Knee System, Legion Hinge Total Knee System, Legion Total Knee System, ZUK Unicompartmental Knee System, ENGAGE Partial Knee System and Porous Patella and Porous Tibial Baseplates |
| Applicant | Smith & Nephew, Inc. |
| Product code | JWH |
| Device class | Class II |
| Decision date | May 4, 2023 |
| Decision | Substantially Equivalent |
| Regulation | 888.3560 |
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