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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 K172189
Device Name Ins Hilden Humeral Arzzt, Ins Hilden Cannulated Tibial Arzzt, Ins Hilden Femoral Arzzt & Ins Hilden Retrograde Femoral Arzzt
Applicant
Truemed Group, LLC
2002 Timberloch Pl., Suite 200
The Woodlands,  TX  77380
Applicant Contact Nina Galeana Rodriguez
Correspondent
Truemed Group, LLC
2002 Timberloch Pl., Suite 200
The Woodlands,  TX  77380
Correspondent Contact Nina Galeana Rodriguez
Regulation Number888.3020
Classification Product Code
HSB  
Date Received07/20/2017
Decision Date 01/16/2018
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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