De Novo DEN220033

Device
MISHA Knee System
Contact
nancy e. issac
De Novo number
DEN220033
Product code
QVV
Regulation
888.3610
Classification name
medial knee implanted shock absorber
Decision
granted (DENG)
Decision date
2023-04-10
Date received
2022-06-06
Classification advisory
Orthopedic
Review advisory
Orthopedic
Type
Direct

Current FDA Classification#

Product code
QVV
Device name
Medial Knee Implanted Shock Absorber
Medical specialty
Orthopedic
Device class
2
Regulation
888.3610
Implant
Y
Life sustain/support
N