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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Rod, Fixation, Intramedullary And Accessories, In-Vivo Cured, Light-Activated
510(k) Number K202887
Device Name IlluminOss Bone Stabilization System
Applicant
IlluminOss Medical, Inc.
993 Waterman Avenue
East Providence,  RI  02914
Applicant Contact Robert Rabiner
Correspondent
MCRA, LLC
1050 K Street NW, Suite 1000
Washington,  DC  20001
Correspondent Contact Hollace Saas Rhodes
Regulation Number888.3023
Classification Product Code
QAD  
Date Received09/28/2020
Decision Date 10/27/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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