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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Rib Replacement
510(k) Number K233105
Device Name RESPONSE™ Rib and Pelvic 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 Number888.3070
Classification Product Code
MDI  
Date Received09/27/2023
Decision Date 01/20/2024
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
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