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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
510(k) Number K220809
Device Name Drive Rail System
Applicant
OrthoPediatrics Corp.
2850 Frontier Dr.
Warsaw,  IN  46582
Applicant Contact Yan Li
Correspondent
OrthoPediatrics Corp.
2850 Frontier Dr.
Warsaw,  IN  46582
Correspondent Contact Yan Li
Regulation Number888.3030
Classification Product Code
KTT  
Subsequent Product Code
JDW  
Date Received03/21/2022
Decision Date 04/08/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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