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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 K142052
Device Name ORTHOFIX GALAXY UNYCO DIAPHYSEAL TIBIA KIT
Applicant
ORTHOFIX SRL
PO BOX 15729
WILMINGTON,  NC  28408
Applicant Contact CHERYL WAGONER
Correspondent
ORTHOFIX SRL
PO BOX 15729
WILMINGTON,  NC  28408
Correspondent Contact CHERYL WAGONER
Regulation Number888.3030
Classification Product Code
KTT  
Date Received07/28/2014
Decision Date 12/05/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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