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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 rod, fixation, intramedullary and accessories, in-vivo cured, light-activated
De Novo Number DEN160062
Device Name IlluminOss Bone Stabilization System
Requester
illminoss medical, inc.
993 waterman ave.
east providence,  RI  02914
Contact fred tobia
Regulation Number888.3023
Classification Product Code
QAD  
Date Received12/28/2016
Decision Date 12/19/2017
Decision granted (DENG)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
Predetermined Change
Control Plan Authorized		 No
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