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ORTHOPEDIATRICS CANADA ULC

Canada · Laval

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Canada — 3 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

16listed device types

Class I 11Class II 5Class III 0

plus 24 registration records and 1 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

7registered devices

Class I 7

13 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

6active device licences

Class II 1Class III 5

17 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

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 States24 registration records, 1 510(k), 0 PMA, 4 excluded

Brazil7 confirmed, 2 excluded

Saudi Arabia0 confirmed, 1 excluded

Canada6 confirmed, 1 excluded

Manufacturer names merged into this page: ORTHOPEDIATRICS CANADA ULC

Registration details (sample)

Market	Identifier	Name	Class / date
US	K241983	Fassier-Duval Telescoping IM System	2025-02-21
BR	80047300834	Kit Instrumental para Sistema de Parafuso de Deslizamento Livre SCFE G	Class I
BR	80047300835	Sistema de Osteotomia Dr. Paley's	Class I
BR	80047300842	Sistema Endo-Exo Medular GAP - Instrumentais	Class I
CA	6252	EASY PLATE CERVICAL SYSTEM	Class III
CA	11772	CRANIO-MAXILLOFACIAL AND SMALL BONES OSTEOSYNTHESIS SYSTEM	Class III
CA	12747	SPHERE TITANIUM SPINAL FIXATION SYSTEM	Class III

ORTHOPEDIATRICS CANADA ULC

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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