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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Fixation, Bone
510(k) Number K162507
Device Name Arzzt 3.5 / 4.5 Small & Large Fragments System
Applicant
Truemed Group, LLC
20507 Nannette Ln.
Sprint,  TX  77388
Applicant Contact Jorge Castillo
Correspondent
Registrar Corp.
144 Research Dr.
Hampton,  VA  23666
Correspondent Contact Lara Luzak
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received09/08/2016
Decision Date 08/03/2017
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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