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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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Device Classification Name medial knee implanted shock absorber
De Novo Number DEN220033
Device Name MISHA Knee System
Requester
moximed, inc.
46602 landing parkway
fremont,  CA  94538
Contact nancy e. issac
Regulation Number888.3610
Classification Product Code
QVV  
Date Received06/06/2022
Decision Date 04/10/2023
Decision granted (DENG)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
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