CG MedTech Co., Ltd.

FDA Device Registration & Listing · Uijeongbu-si Gyeonggi, KR · Registration 9617297

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
9617297
FEI Number
3003200961
Entity Name
CG MedTech Co., Ltd.
City/State/Country
Uijeongbu-si Gyeonggi, KR
Establishment Address
20, Sandan-ro 76beon-gil(Rd), Uijeongbu-si Gyeonggi 11781, KR
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device
Owner / Operator
CG MedTech Co., Ltd. (Owner Number: 9045343)
Owner / Operator Contact Address
20, Sandan-ro 76beon-gil(Rd), Uijeongbu-si, KR-41 11781, KR
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Plate Bender Rod bender extended ROD BENDER Polarfix™ Facet Screw System ASPIRON ACP System ANAX 5.5 Spinal System Large Round Poly Screw Driver Round Poly Screw Driver Screw Adjustment Instrument Poly Driver Poly Screw Driver Cannulated Guide Driver for HP Screw 4mm Driver with Adaptor Screw Driver& Holder Mini T Poly Screw Driver Set Screw Driver Screw Driver Mono Screw Driver Extended Hex Driver 3.5mm Cannulated 4mm Driver Dr. Ahn Poly Driver 4mm Driver with Adaptor 4 Hex POLY SCREW DRIVER 2.5MM HEX DRIVER LARGE POLY SCREW DRIVER MONO SCREW DRIVER Velofix™ TLIF Cage ANAX™ OCT Spinal System Perfix Spinal System Velofix™ SA Cervical Cage Drill Guide Holder(Plate,Hook,Rod,Housing,T-Lin Set Screw Guide Extended Set Screw Inserting Guide Guide Driver Poly Head Adjuster Temporary Fixation Pin Driver Alignment Guide LOCKING CAP DRIVER GUIDE PIN DRIVER HOUSING HOLDER TAP GUIDE SET SCREW DRIVER GUIDE ANTI TORQU ROD HOLDER ASPIRON™ S ACP SYSTEM Probe Cannulated Probe Straight Guide Probe Sphere Handle Curved Probe Sphere Handle Probe Reaming Probe PROBE CURVED PROBE Forceps IN-SITU ROD BENDER-RIGHT IN-SITU ROD BENDER-LEFT ROD FORK COMPRESSOR DRILL BIT FOR D4 DRILL BIT FOR D3.5 MULTIPLE DRILL BITS ADJUSTABLE DRILL BITS Bone Impactor HOOK IMPACTOR DYNA LOCKING TROCHANTERIC NAIL INNOVERSE Spinal System Reamer Velofix™ TLIF Cage ASPIRON ACP SYSTEM Axial Torque Wrench 4 Hex Derotation Wrench Torque Wrench(GSFS,Transverse link) TORQUE WRENCH FOR T LINK-COLLET TYP AXIAL TORQUE WRENCH DEROTATOR Handle(Persuader-T,FD Ratchet) Handle(Palm,I,T,Driving) Adjustable Stopper Handle(Ratchet-T Cannulated) Extender Handle(Ratchet-T,Ratchet Palm) Temporary Fixation Pin Distractor(Converging,Diverging) Torque Limiting T-Handle Retractor Fixation Pin DRIVER SHAFT LG) GUIDE PIN (SM POLY SCREW DRIVER TESTER(STRAIGHT SPREADER ROCKER CURVED) PERSUADER RATCHET HA ANAX 5.5 Spinal System Velofix Interbody Fusion System ROD TEMPLATE 400MM ROD TEMPLATE 200MM INNOVERSE Navigation Instruments Awl Extended Awl Cannulated AWL Slide hammer ANAX™ 5.5 SPINAL SYSTEM Velofix™ SA Cervical Cage Cannulated Tap Sharp Tap Adjustable Tap TAP-6.OMM TAP-4.5MM TAP-7MM TAP-7.5MM TAP-3.5MM TAP-8MM TAP-5.OMM TAP-4.OMM Rasp UniSpace® Stand-Alone C Cage Anax™ 5.5 MIS system Anax™ MIS system ANAX™ 5.5 Spinal System Velofix Interbody Fusion System ANAX™ 5.5 CT SPINAL SYSTEM Retractor ANAX™ 5.5 Spinal System Surgical Tray

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HXW Bender Orthopedic Class 1 888.4540 2005-01-18
MRW System, Facet Screw Spinal Device Unknown Class U N/A 2018-01-09
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-12-27
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-12-27
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-12-27
HXX Screwdriver Orthopedic Class 1 888.4540 2005-01-18
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2019-07-10
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2018-12-27
NKG Posterior Cervical Screw System Orthopedic Class 2 888.3075 2018-12-27
PEK Spinous Process Plate Orthopedic Class 2 888.3050 2015-09-03
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2010-12-15
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2010-12-15
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2021-11-21
FZX Guide, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2005-01-18
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2018-09-11
HXB Probe Orthopedic Class 1 888.4540 2005-01-18
GEN Forceps, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2013-01-23
HXP Instrument, Bending Or Contouring Orthopedic Class 1 888.4540 2005-01-18
HXE Fork Orthopedic Class 1 888.4540 2005-01-18
HWN Instrument, Compression Orthopedic Class 1 888.4540 2005-01-18
HTW Bit, Drill Orthopedic Class 1 888.4540 2006-07-28
HWA Impactor Orthopedic Class 1 888.4540 2006-06-30
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2023-05-16
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2023-05-16
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2024-02-12
HTO Reamer Orthopedic Class 1 888.4540 2010-12-31
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2017-12-08
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2016-09-12
HXC Wrench Orthopedic Class 1 888.4540 2005-01-18
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2005-01-18
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2014-03-11
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2014-03-11
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2015-03-06
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2015-03-06
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2014-07-31
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2014-07-31
HWT Template Orthopedic Class 1 888.4800 2005-01-18
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2024-07-07
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2024-07-07
HWJ Awl Orthopedic Class 1 888.4540 2005-01-18
FZY Hammer, Surgical General, Plastic Surgery Class 1 878.4800 2010-12-31
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2017-12-13
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2017-12-07
HWX Tap, Bone Orthopedic Class 1 888.4540 2005-01-18
HTR Rasp General, Plastic Surgery Class 1 878.4800 2008-12-23
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2024-04-26
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2016-09-08
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2016-09-08
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2017-07-17
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2018-12-17
GAD Retractor General, Plastic Surgery Class 1 878.4800 2006-07-28
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2023-12-17
LRP Tray, Surgical General, Plastic Surgery Class 1 878.4800 2013-01-23

Official Correspondent

Jae-Hong Kim

US Agent Details

Cori Ragan Business: Cori Ragan Email: Cori.Ragan@fortrea.com Phone: (612) 4834578

Related Public Records

Same Entity

CG MedTech Co., Ltd.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3009554293 CG MedTech USA, Inc. Irvine, CA, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K173198 U&I Corporation Facet Screw Fixation System 2018-01-03
K121850 Choicespine, LP Typhoon(TM) Facet Screw Fixation System 2012-09-20
K032752 R&B Surgical Solutions, LLC R&B SURGICAL SMARTPLATE CERVICAL PLATE SYSTEM 2003-12-03
K062643 Life Spine KINETIC ANTERIOR CERVICAL PLATE 2006-11-16
K012175 Encore Orthopedics, Inc. PASS SPINAL SYSTEM 2001-07-31

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0008-2012 Osteomed, Lp 3885 Arapaho Rd Addison TX 75001 U
OSTEOMED SPINE Facet Fixation System PrimaLOK FF Threaded Implant Driver Shaft OsteoMed L.P. 3885 Arapaho Road, Addison, Texas 75001
Z-0036-2013 Medtronic Sofamor Danek USA Inc 2
ATLANTIS(R) Anterior Cervical Plate System VARIABLE ANGLE SCREW MODULE, REF 176-503, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for single use, this instrument may be re-used.
Z-0037-2013 Medtronic Sofamor Danek USA Inc 2
ATLANTIS(R) Anterior Cervical Plate System FIXED ANGLE SCREW MODULE, REF 176-504, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for single use, this instrument may be re-used.
Z-0038-2013 Medtronic Sofamor Danek USA Inc 2
PREMIER(R) Anterior Cervical Plate System SCREW BLOCK, REF 1860503, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for single use, this instrument may be re-used.
Z-0040-05 Zimmer Spine, Inc. 2
ATO Drill Guide Kit (All Through One Drill Guides Set), model number 07.00860.001, product is packaged in trays.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9617297. Last updated year: 2026. Please use registration number 9617297 when referencing this establishment in official correspondence.
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