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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 screw sleeve bone fixation device
De Novo Number DEN180065
Device Name OGmend Implant System
Requester
woven orthopedic technologies, llc
63 e. center street
manchester,  CT  06040
Contact bob luzzi
Regulation Number888.3043
Classification Product Code
QAC  
Date Received12/13/2018
Decision Date 05/01/2020
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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