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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 K170146
Device Name Galaxy UNYCO System
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 Wagoner
Regulation Number888.3030
Classification Product Code
KTT  
Date Received01/17/2017
Decision Date 10/12/2017
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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