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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pin, Fixation, Smooth
510(k) Number K173051
Device Name Orthofix MJ-FLEX THE NEW METAIZEAU NAIL
Applicant
Orthofix Srl
Via Delle Nazioni 9
Bussolengo,  IT 37012
Applicant Contact Gianluca Ricadona
Correspondent
Wagoner Consulting, LLC
P.O. Box 15729
Wilmington,  NC  24408
Correspondent Contact Chery Wagoner
Regulation Number888.3040
Classification Product Code
HTY  
Subsequent Product Code
HWC  
Date Received09/28/2017
Decision Date 11/16/2017
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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