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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 K133166
Device Name INS HILDEN TIBIAL ARZZT
Applicant
Truemed Group, LLC
144 Research Dr.
Hampton,  VA  23669
Applicant Contact RHONDA ALEXANDER
Correspondent
Truemed Group, LLC
144 Research Dr.
Hampton,  VA  23669
Correspondent Contact RHONDA ALEXANDER
Regulation Number888.3020
Classification Product Code
HSB  
Date Received10/17/2013
Decision Date 11/06/2014
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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