Microport Orthopedics, Inc. · Class II · Cleared Apr 1, 2024
| K-number | K240043 |
| Device name | EVOLUTION® Hinge Knee System;GUARDIAN limb Salvage System;DCW Modular Distal Femoral System;REPIPHYSIS Limb Salvage System;EVOLUTION® MP Total Knee System; EVOLUTION® MP Total Knee System; EVOLUTION® MP Adaptive CS Insert; EVOLUTION® MP Adaptive PS Tibial Insert; EVOLUTION® MP CS/CR Porous Femur/EVOLUTION® Adaptive CS and PS Inserts; EVOLUTION® Revision CCK System; ADVANCE® Double High Insert; ADVANCE® A-CLASS® Tibial Insert; ADVANCE® Knee System; ADVANCE® Ultra-Congruent Tibial Inse |
| Applicant | Microport Orthopedics, Inc. |
| Product code | KRO |
| Device class | Class II |
| Decision date | Apr 1, 2024 |
| Decision | Substantially Equivalent |
| Regulation | 888.3510 |
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