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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 avenue
east providence, RI 02914
Contact
fred tobia
Regulation Number
888.3023
Classification Product Code
QAD
Date Received
12/28/2016
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
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