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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 K152627
Device Name IFS Fixation Scaffold System
Applicant
Metric Medical Devices, Inc.
846 Silver Springs
Helotes,  TX  78023
Applicant Contact W.Casey Fox
Correspondent
Metric Medical Devices, Inc.
846 Silver Springs
Helotes,  TX  78023
Correspondent Contact W.Casey Fox
Regulation Number888.3040
Classification Product Code
HTY  
Date Received09/15/2015
Decision Date 01/13/2016
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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