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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name plate, fixation, bone
510(k) Number K140431
Device Name PEDILOC FRAGMENT SYSTEM
Applicant
ORTHOPEDIATRICS, CORP.
2850 FRONTIER DRIVE
WARSAW,  IN  46582
Applicant Contact MARK FOX
Correspondent
ORTHOPEDIATRICS, CORP.
2850 FRONTIER DRIVE
WARSAW,  IN  46582
Correspondent Contact MARK FOX
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Codes
HTN   HWC   KTT  
Date Received02/20/2014
Decision Date 07/29/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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