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CG MedTech USA, Inc.

USA · Irvine

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Brazil — 2 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

38listed device types

Class I 24Class II 13Class III 0unclassified 1

plus 112 registration records and 2 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

13registered devices

Class I 13

21 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

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 States112 registration records, 2 510(k), 0 PMA, 3 excluded

Brazil13 confirmed, 2 excluded

Canada0 confirmed, 1 excluded

Manufacturer names merged into this page: CG MedTech USA, Inc. · CG MedTech Co., Ltd. · CG MEDTECH CO., LTD.

FDA 510(k) clearances by year

22025 · K252351

FDA listed device types

showing 8 of 38

Posterior Cervical Screw System 1Rod, Fixation, Intramedullary And Accessories 1Thoracolumbosacral Pedicle Screw System 1Appliance, Fixation, Spinal Intervertebral Body 1Pin, Fixation, Smooth 1Orthosis, Spinal Pedicle Fixation 1Orthosis, Spondylolisthesis Spinal Fixation 1Intervertebral Fusion Device With Bone Graft, Lumbar 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K252351	UniSpace® TPLIF Cage	2025-10-28
US	K251725	ANAX OCT Spinal System	2025-06-25
BR	10355870326	Instrumentos CG MedTech PPSU	Class I
BR	10355870327	Instrumentos CG MedTech Ti	Class I
BR	10355870267	Instrumentos CG MedTech AC	Class I

CG MedTech USA, Inc.

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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