IlluminOss Bone Stabilization System

Rod, Fixation, Intramedullary And Accessories, In-vivo Cured, Light-activated

IlluminOss Medical, Inc.

The following data is part of a premarket notification filed by Illuminoss Medical, Inc. with the FDA for Illuminoss Bone Stabilization System.

Pre-market Notification Details

Device IDK200295
510k NumberK200295
Device Name:IlluminOss Bone Stabilization System
ClassificationRod, Fixation, Intramedullary And Accessories, In-vivo Cured, Light-activated
Applicant IlluminOss Medical, Inc. 993 Waterman Avenue East Providence,  RI  02914
ContactRobert Rabiner
CorrespondentRobert Rabiner
MRCA, LLC 993 Waterman Avenue East Providence,  RI  02914
Product CodeQAD  
CFR Regulation Number888.3023 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-02-05
Decision Date2020-06-25

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