Atlas FDA

QVV

1 FDA 510(k) clearances · Product code

FDA profile

Official device name
Medial Knee Implanted Shock Absorber
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3610
Medical specialty
Orthopedic
Flags
Implant
FDA definition
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.
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RecordFirmDateBuilder
MISHA Knee System (DEN220033)Moximed, Inc.2023-04-10

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