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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 K172583
Device Name OrthoPediatrics PediNail Intramedullary Platform
Applicant
Orthopediatrics, Inc.
2850 Frontier Dr.
Warsaw,  IN  46582
Applicant Contact Adam Cargill
Correspondent
Orthopediatrics, Inc.
2850 Frontier Dr.
Warsaw,  IN  46582
Correspondent Contact James L. Crumley
Regulation Number888.3020
Classification Product Code
HSB  
Date Received08/28/2017
Decision Date 05/10/2018
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
Recalls CDRH Recalls
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