BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    CG MedTech Co., Ltd.

    Reg #: 9617297 · FEI: 3003200961 · Expires 2026
    View on FDA
    Products
    38
    Proprietary Names
    138
    Establishment Types
    2
    Classifications
    38

    Registration Details

    Registration Name
    CG MedTech Co., Ltd.
    Registration Number
    9617297
    FEI Number
    3003200961
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    20, Sandan-ro 76beon-gil(Rd)
    City
    Uijeongbu-si Gyeonggi
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K173198

    Owner / Operator

    Firm Name
    CG MedTech Co., Ltd.
    Operator Number
    9045343
    Address
    20, Sandan-ro 76beon-gil(Rd)
    City
    Uijeongbu-si
    State
    Gyeonggi
    Postal Code
    11781
    Country
    KR
    Correspondent
    Jae-Hong Kim

    US Agent

    Business Name
    Cori Ragan
    Contact Name
    Cori Ragan
    Address
    8 Moore Drive Durham, North Carolina
    City
    Durham
    State
    NC
    ZIP
    27713
    Country
    US
    Email
    [email protected]
    Phone
    612 4834578

    Products

    Device Name Product Code
    Bender HXW
    System, Facet Screw Spinal Device MRW
    Appliance, Fixation, Spinal Intervertebral Body KWQ
    Orthosis, Spinal Pedicle Fixation MNI
    Orthosis, Spondylolisthesis Spinal Fixation MNH
    Screwdriver HXX
    Intervertebral Fusion Device With Bone Graft, Lumbar MAX
    Appliance, Fixation, Spinal Interlaminal KWP
    Posterior Cervical Screw System NKG
    Spinous Process Plate PEK
    Intervertebral Fusion Device With Integrated Fixation, Cervical OVE
    Guide, Surgical, Instrument FZX
    Probe HXB
    Forceps, General & Plastic Surgery GEN
    Instrument, Bending Or Contouring HXP
    Fork HXE
    Instrument, Compression HWN
    Bit, Drill HTW
    Impactor HWA
    Rod, Fixation, Intramedullary And Accessories HSB
    Pin, Fixation, Smooth HTY
    Thoracolumbosacral Pedicle Screw System NKB
    Reamer HTO
    Wrench HXC
    Orthopedic Manual Surgical Instrument LXH
    Intervertebral Fusion Device With Bone Graft, Cervical ODP
    Template HWT
    Orthopedic Stereotaxic Instrument OLO
    Awl HWJ
    Hammer, Surgical FZY
    Tap, Bone HWX
    Rasp HTR
    Retractor GAD
    Tray, Surgical LRP
    Cutter, Surgical FZT
    Pusher, Socket HXO
    Gauge, Depth HTJ
    Tray, Surgical, Instrument FSM

    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 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 TESTER(STRAIGHT SPREADER ROCKER CURVED) PERSUADER RATCHET HA 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 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 ANAX™ 5.5 CT SPINAL SYSTEM Retractor Surgical Tray Reduction Cutter Surgical Cutter ROD CUTTER REDUCTION HOUSING CUTTER ROD PUSHER Screw gauge UniSpace® TPLIF Cage Various Types of Covers Various Types of Trayes Various Types of Containers Various Types of Cases SURGICAL INSTRUMENT TRAY ANAX OCT Spinal System Dyna Locking Trochanteric Nail Perfix Iliac Screw System ASPIRON™ S ACP System

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device