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OrthoPediatrics Corporation

USA · Warsaw

✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, Australia, Israel — 8 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

64listed device types

Class I 43Class II 21Class III 0

plus 90 registration records and 44 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

23registered devices

Class I 20Class II 3

38 including historic records

SASaudi ArabiaSFDA

13registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

29 including historic records

TWTaiwanTFDA

10valid device licences

Class II 10

SGSingaporeHSA SMDR

6device registrations

CLASS C 6

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

36active ARTG entries

Class I 8IIa 9IIb 19

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

5registrations

RURussiaRoszdravnadzor

pendingnot queried

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States90 registration records, 44 510(k), 0 PMA, 2 excluded

Brazil23 confirmed, 1 excluded

Saudi Arabia13 confirmed, 0 excluded

Canada0 confirmed, 1 excluded

Manufacturer names merged into this page: ORTHOPEDIATRICS, CORP · ORTHOPEDIATRICS CORPORATION · ORTHOPEDIATRICS CORP · OrthoPediatrics Corporation · OrthoPediatrics Corp,.

Business registration

Legal name: ORTHOPEDIATRICS CORP
CIK: 0001425450
Registration status: Active
Listing status: Listed (KIDS)

Business registration data from SEC EDGAR, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

FDA 510(k) clearances by year

52008

32009

12010

22011

22012

22013

12014

12015

32016

22017

22018

32019

22020

22021

22022

32023

12024

62025

12026

FDA listed device types

showing 8 of 64

Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component 1Prosthesis, Rib Replacement 1Rod, Fixation, Intramedullary And Accessories 1Thoracolumbosacral Pedicle Screw System 1Screw, Fixation, Bone 1Washer, Bolt Nut 1Appliance, Fixation, Spinal Interlaminal 1Pin, Fixation, Smooth 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K260323	OrthoPediatrics® Locking Cannulated Blade Plate System	2026-04-30
US	K252600	Pediatric Plating Platform I Small-Mini	2025-10-09
US	K251362	PediFlex Flexible Nail System	2025-06-24
BR	80047300744	orthex	Class I
BR	80047300745	KIT INSTRUMENTAL ORTHEX	Class I
BR	80047309233	Orthopediatrics Instrumentation	Class II
SA	ME0000005734SFDAA00014	FOOT PUSHER PLATFORM	—
SA	ME0000005734SFDAA00010	FOOT PUSHER KNOB	—

OrthoPediatrics Corporation

Registrations by market

How these numbers were verified

Company information

Business registration

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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