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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 K153233
Device Name Galaxy UNYCO System
Applicant
ORTHOFIX SRL
VIA DELLE NAZIONI 9
BUSSOLENGO,  IT 37012
Applicant Contact GIANLUCA RICADONA
Correspondent
WAGONER CONSULTING LLC
PO BOX 15729
WILMINGTON,  NC  28408
Correspondent Contact CHERYL WAGONER
Regulation Number888.3030
Classification Product Code
KTT  
Date Received11/09/2015
Decision Date 01/06/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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