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Data / Medical devices / South Korea / CG MedTech Co., Ltd.

CG MedTech Co., Ltd.: FDA-registered device maker in Uijeongbu-si Gyeonggi, South Korea, 32 510(k) clearances

CG MedTech Co., Ltd. is registered with the FDA (registration 9617297) in Uijeongbu-si Gyeonggi, South Korea. It lists 38 device types. The FDA files 32 510(k) clearances under its listings, the newest dated October 28, 2025. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch CG MedTech Co., Ltd.
FDA registration number
9617297
FEI number
3003200961
Address
20, Sandan-ro 76beon-gil(Rd), Uijeongbu-si Gyeonggi, South Korea, 11781
Owner or operator
CG MedTech Co., Ltd. (9045343)
Roles
Complaint file establishment, Manufacturer
First device listed
January 18, 2005
Registered through
2026
Brand names listed
2.5MM HEX DRIVER, 4mm Driver, 4mm Driver with Adaptor, 4mm Driver with Adaptor 4 Hex, ADJUSTABLE DRILL BITS, ANAX 5.5 Spinal System, ANAX OCT Spinal System, ANAX™ 5.5 CT SPINAL SYSTEM and more

Devices it lists

DeviceProduct codeClassRoleSource
Appliance, Fixation, Spinal InterlaminalKWP2Manufactureraccessdata.fda.gov
Appliance, Fixation, Spinal Intervertebral BodyKWQ2Manufactureraccessdata.fda.gov
AwlHWJ1Complaint file establishment, Manufactureraccessdata.fda.gov
BenderHXW1Complaint file establishment, Manufactureraccessdata.fda.gov
Bit, DrillHTW1Complaint file establishment, Manufactureraccessdata.fda.gov
Cutter, SurgicalFZT1Complaint file establishment, Manufactureraccessdata.fda.gov
Forceps, General & Plastic SurgeryGEN1Complaint file establishment, Manufactureraccessdata.fda.gov
ForkHXE1Complaint file establishment, Manufactureraccessdata.fda.gov
Gauge, DepthHTJ1Complaint file establishment, Manufactureraccessdata.fda.gov
Guide, Surgical, InstrumentFZX1Manufactureraccessdata.fda.gov
Hammer, SurgicalFZY1Complaint file establishment, Manufactureraccessdata.fda.gov
ImpactorHWA1Complaint file establishment, Manufactureraccessdata.fda.gov
Instrument, Bending Or ContouringHXP1Complaint file establishment, Manufactureraccessdata.fda.gov
Instrument, CompressionHWN1Complaint file establishment, Manufactureraccessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, CervicalODP2Manufactureraccessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, LumbarMAX2Manufactureraccessdata.fda.gov
Intervertebral Fusion Device With Integrated Fixation, CervicalOVE2Manufactureraccessdata.fda.gov
Orthopedic Manual Surgical InstrumentLXH1Complaint file establishment, Manufactureraccessdata.fda.gov
Orthopedic Stereotaxic InstrumentOLO2Manufactureraccessdata.fda.gov
Orthosis, Spinal Pedicle FixationMNI2Complaint file establishment, Manufactureraccessdata.fda.gov
Orthosis, Spondylolisthesis Spinal FixationMNH2Complaint file establishment, Manufactureraccessdata.fda.gov
Pin, Fixation, SmoothHTY2Manufactureraccessdata.fda.gov
Posterior Cervical Screw SystemNKG2Manufactureraccessdata.fda.gov
ProbeHXB1Manufactureraccessdata.fda.gov
Pusher, SocketHXO1Complaint file establishment, Manufactureraccessdata.fda.gov
RaspHTR1Complaint file establishment, Manufactureraccessdata.fda.gov
ReamerHTO1Complaint file establishment, Manufactureraccessdata.fda.gov
RetractorGAD1Complaint file establishment, Manufactureraccessdata.fda.gov
Rod, Fixation, Intramedullary And AccessoriesHSB2Manufactureraccessdata.fda.gov
ScrewdriverHXX1Complaint file establishment, Manufactureraccessdata.fda.gov
Spinous Process PlatePEK2Manufactureraccessdata.fda.gov
System, Facet Screw Spinal DeviceMRWUManufactureraccessdata.fda.gov
Tap, BoneHWX1Complaint file establishment, Manufactureraccessdata.fda.gov
TemplateHWT1Complaint file establishment, Manufactureraccessdata.fda.gov
Thoracolumbosacral Pedicle Screw SystemNKB2Manufactureraccessdata.fda.gov
Tray, SurgicalLRP1Complaint file establishment, Manufactureraccessdata.fda.gov
Tray, Surgical, InstrumentFSM1Complaint file establishment, Manufactureraccessdata.fda.gov
WrenchHXC1Manufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
October 28, 2025K252351UniSpace® TPLIF CageMAXSubstantially EquivalentCg Medtech Co., Ltd.accessdata.fda.gov
June 25, 2025K251725ANAX™ OCT Spinal SystemNKGSubstantially EquivalentCg Medtech Co., Ltd.accessdata.fda.gov
June 14, 2024K241082INNOVERSE Navigation InstrumentsOLOSubstantially EquivalentInnosys Co., Ltd.accessdata.fda.gov
April 19, 2024K234119UniSpace® Stand-Alone C CageOVESubstantially EquivalentInnosys Co., Ltd.accessdata.fda.gov
February 6, 2024K233960INNOVERSE Spinal SystemNKBSubstantially EquivalentInnosys Co., Ltd.accessdata.fda.gov
October 26, 2023K231737ANAX™ 5.5 Spinal SystemNKBSubstantially EquivalentInnosys Co., Ltd.accessdata.fda.gov
March 3, 2023K221084Dyna Locking Trochanteric Nail™HSBSubstantially EquivalentInnosysaccessdata.fda.gov
February 16, 2022K220147Aspiron S ACP SystemKWQSubstantially EquivalentU&I Corporationaccessdata.fda.gov
November 19, 2021K210573Velofix SA Cervical CageOVESubstantially EquivalentU&I Corporationaccessdata.fda.gov
July 10, 2019K183243Velofix TLIF CageMAXSubstantially EquivalentU&I Corporationaccessdata.fda.gov
February 1, 2019K190053SECULOK™ ACP SystemKWQSubstantially EquivalentU&I Corporationaccessdata.fda.gov
December 13, 2018K181824CBT Screw Fixation SystemNKBSubstantially EquivalentU&I Corporationaccessdata.fda.gov
December 12, 2018K183383ANAX™ OCT Spinal SystemNKGSubstantially EquivalentU&I Corporationaccessdata.fda.gov
November 14, 2018K181829Velofix TLIF CageMAXSubstantially EquivalentU&I Corporationaccessdata.fda.gov
September 10, 2018K182055SECULOK™ ACP SystemKWQSubstantially EquivalentU&I Corporationaccessdata.fda.gov
January 3, 2018K173198Facet Screw Fixation SystemMRWSubstantially EquivalentU&I Corporationaccessdata.fda.gov
December 13, 2017K173524ANAX 5.5™ Spinal SystemNKBSubstantially EquivalentU&I Corporationaccessdata.fda.gov
December 4, 2017K172419Velofix™ TLIF CageMAXSubstantially EquivalentU&I Corporationaccessdata.fda.gov
November 22, 2017K172424Velofix™ SA Cervical CageOVESubstantially EquivalentU&I Corporationaccessdata.fda.gov
July 13, 2017K171749Velofix(tm) Interbody Fusion SystemODPSubstantially EquivalentU&I Corporationaccessdata.fda.gov
August 30, 2016K162189ANAX™ 5.5 Spinal SystemMNHSubstantially EquivalentU&I Corporationaccessdata.fda.gov
September 3, 2015K143631Benefix Interspinous Fixation SystemPEKSubstantially EquivalentU&I Corporationaccessdata.fda.gov
June 3, 2015K150570ANAX OCT Spinal SystemNKGSubstantially EquivalentU&I Corporationaccessdata.fda.gov
February 25, 2015K143417ANAX 5.5 Spinal SystemMNHSubstantially EquivalentU&I Corporationaccessdata.fda.gov
July 22, 2014K140864VELOXTM INTERBODY FUSION SYSTEMODPSubstantially EquivalentU&I Corp.accessdata.fda.gov
June 2, 2014K140234ASPIRON ACP SYSTEMKWQSubstantially EquivalentU&I Corp.accessdata.fda.gov
March 5, 2014K132926VELOFIXTM INTERBODY FUSION SYSTEMODPSubstantially EquivalentU&I Corp.accessdata.fda.gov
December 17, 2013K132218PERFIX ILIAC SCREW SYSTEMMNHSubstantially EquivalentU&I Corporationaccessdata.fda.gov
November 25, 2013K132101ANAX 5.5 SPINAL SYSTEMMNHSubstantially EquivalentU&I Corporationaccessdata.fda.gov
August 29, 2013K131200ASPIRON ACP SYSTEMKWQSubstantially EquivalentU&I Corporationaccessdata.fda.gov
June 23, 2010K093707DYNA LOCKING TROCHANTERIC NAIL, MODEL NG0820HSBSubstantially EquivalentU&I Corp.accessdata.fda.gov
November 9, 2009K091725PERFIX SPINAL SYSTEM, MODEL SNA4530-9610, SNM4530-9610, SN3020 (TOTAL: 549)MNHSubstantially EquivalentU&I Corp.accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

InitiatedEventClassStatusProductReasonSource
May 26, 202085841Class IITerminatedANAX 5.5 Poly-Reduction Screw 6.0X50MM, REF: SFNA6050R, part of ANAX 5.5 SPINAL SYSTEM6.0x50mm poly-reduction screws were laser etched 6.0x45accessdata.fda.gov
January 30, 201984989Class IITerminatedVelofix SA cervical cage, REF: TSA161207, TSA161208, TSA161209, TSA161210, TSA161407, TSA161408, TSA161409, TSA161410 - Product Usage:The device is indicated for anterior cervical interbody fusion procedures in skeletallThe vertical dimensions of screw-hole position in some standalone cages might be out of range in engineering drawings. A possibility exists of screw pullout, lossening, instability, or less bone-screw engagement than intended by physicians.accessdata.fda.gov

Compare with other makers

Updated October 28, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.