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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
510(k) Number K201147
Device Name Elos® Intramedullary Nailing System
Applicant
Intrauma S.P.A
Via Genova 19
Rivoli (To),  IT 10098
Applicant Contact Piero Costa
Correspondent
MCRA, LLC
1050 K. St. NW
Suite 1000
Washington,  DC  20001
Correspondent Contact Hollace Saas Rhodes
Regulation Number888.3020
Classification Product Code
HSB  
Date Received04/29/2020
Decision Date 07/19/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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