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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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