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510(k) DEN220033

MISHA Knee System by Moximed, Inc. — Product Code QVV

Clearance Details

Decision: DENG (De Novo Granted)
Decision Date: April 10, 2023
Date Received: June 6, 2022
Clearance Type: Direct
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Medial Knee Implanted Shock Absorber
Device Class: Class II
Regulation Number: 888.3610
Review Panel: OR
Submission Type

A medial knee implanted shock absorber is a device implanted outside of the knee capsule extending from the distal femur to the proximal tibia. It is intended to reduce loads on the intra-articular medial joint surface. The device employs a shock absorbing mechanical system and is biomechanically stabilized by plates and screws. The device is not intended to span the lateral knee.