FDA 510(k) Applications Submitted by ORTHOPEDIATRICS CORP.

FDA 510(k) Number Submission Date Device Name Applicant
K200097 01/16/2020 Response BandLoc Spinal Fixation OrthoPediatrics Corp.
K222105 07/18/2022 RESPONSE 5.5/6.0 Cannulated Screw System OrthoPediatrics Corp.
K161267 05/05/2016 Response BandLoc Spinal Fixation ORTHOPEDIATRICS CORP.
K220679 03/08/2022 Pediatric Nailing Platform Femur OrthoPediatrics Corp.
K220809 03/21/2022 Drive Rail System OrthoPediatrics Corp.
K231266 05/02/2023 Pediatric Nailing Platform Tibia OrthoPediatrics Corp.
K201838 07/02/2020 PediFlex Flexible Nail System OrthoPediatrics Corp.
K223786 12/19/2022 Orthex External Fixation System OrthoPediatrics Corp.


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