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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
510(k) Number K170650
Device Name Orthofix TrueLok Hexapod System (TL-HEX) V2.0
Applicant
Orthofix Srl
Via Delle Nazioni 9
Bussolengo,  IT 37012
Applicant Contact Gianluca Ricadona
Correspondent
Wagoner Consulting, LLC
P.O. Box 15729
Wilmington,  NC  28408
Correspondent Contact Cheryl Wagonar
Regulation Number888.3030
Classification Product Code
KTT  
Subsequent Product Code
OSN  
Date Received03/03/2017
Decision Date 05/10/2017
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
Recalls CDRH Recalls
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