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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 K160972
Device Name Gexfix External Fixation
Applicant
Gexfix International Corp.
55 NE Ave., Suite 501
Boca Raton,  FL  33432
Applicant Contact Maurizio Longo
Correspondent
Donawa Lifescience Consulting Srl
Piazza Albania 10
Rome,  IT 00153
Correspondent Contact ROGER GRAY
Regulation Number888.3030
Classification Product Code
KTT  
Date Received04/06/2016
Decision Date 12/28/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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