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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 K162307
Device Name OrthoPediatrics Locking Proximal Femur System Cortical Screws
Applicant
ORTHOPEDIATRICS, CORP.
2850 FRONTIER DRIVE
WARSAW,  IN  46582
Applicant Contact ADAM CARGILL
Correspondent
ORTHOPEDIATRICS, CORP.
2850 FRONTIER DRIVE
WARSAW,  IN  46582
Correspondent Contact ADAM CARGILL
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received08/17/2016
Decision Date 09/27/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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