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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Thoracolumbosacral Pedicle Screw System
510(k) Number K222105
Device Name RESPONSE 5.5/6.0 Cannulated Screw System
Applicant
Orthopediatrics Corp.
2850 Frontier Dr.
Warsaw,  IN  46582
Applicant Contact Jennifer Gregory
Correspondent
Orthopediatrics Corp.
2850 Frontier Dr.
Warsaw,  IN  46582
Correspondent Contact Jennifer Gregory
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Code
KWP  
Date Received07/18/2022
Decision Date 03/23/2023
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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