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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Rod, Fixation, Intramedullary And Accessories
510(k) Number K163488
Device Name Flex-Thread Clavicle Pin System
Applicant
Intrafuse, LLC
124 S. 600 W.
Suite 100
Logan,  UT  84321
Applicant Contact Robert Hoy
Correspondent
Intrafuse, LLC
124 S. 600 W.
Suite 100
Logan,  UT  84321
Correspondent Contact Robert Hoy
Regulation Number888.3020
Classification Product Code
HSB  
Subsequent Product Code
JDW  
Date Received12/12/2016
Decision Date 03/20/2017
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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