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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 K171173
Device Name OrthoPediatrics Titanium PediPlates® System
Applicant
OrthoPediatrics, Corp.
2850 Frontier Drive
Warsaw,  IN  46580
Applicant Contact Adam Cargill
Correspondent
OrthoPediatrics, Corp.
2850 Frontier Drive
Warsaw,  IN  46580
Correspondent Contact Adam Cargill
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received04/21/2017
Decision Date 08/24/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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