BEUDAMED
    FDA Registration Active 🇺🇸 United States

    CG MedTech USA, Inc.

    Reg #: 3009554293 · FEI: 3009554293 · Expires 2026
    View on FDA
    Products
    38
    Proprietary Names
    138
    Establishment Types
    1
    Classifications
    38

    Registration Details

    Registration Name
    CG MedTech USA, Inc.
    Registration Number
    3009554293
    FEI Number
    3009554293
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    41 Corporate Park Suite 200
    City
    Irvine
    State
    CA
    ZIP
    92606
    Country
    US

    Regulatory Submissions

    510(k) Number
    K181824

    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

    Products

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

    Proprietary Names

    ANAX™ 5.5 CT SPINAL SYSTEM COMPRESSOR Retractor Velofix™ SA Cervical Cage UniSpace® TPLIF Cage Velofix™ TLIF Cage Bone Impactor HOOK IMPACTOR Forceps ASPIRON™ S ACP System Reamer 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 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 INNOVERSE Spinal System ASPIRON ACP System ANAX™ OCT Spinal System Surgical Tray Awl Extended Awl Cannulated AWL ROD TEMPLATE 400MM ROD TEMPLATE 200MM Reduction Cutter Surgical Cutter ROD CUTTER REDUCTION HOUSING CUTTER DYNA LOCKING TROCHANTERIC NAIL Plate Bender Rod bender extended ROD BENDER IN-SITU ROD BENDER-RIGHT IN-SITU ROD BENDER-LEFT INNOVERSE Navigation Instruments DRILL BIT FOR D4 DRILL BIT FOR D3.5 MULTIPLE DRILL BITS ADJUSTABLE DRILL BITS Polarfix™ Facet Screw System Axial Torque Wrench 4 Hex Derotation Wrench Torque Wrench(GSFS,Transverse link) TORQUE WRENCH FOR T LINK-COLLET TYP AXIAL TORQUE WRENCH DEROTATOR Rasp Probe Cannulated Probe Straight Guide Probe Sphere Handle Curved Probe Sphere Handle Probe Reaming Probe PROBE CURVED PROBE ANAX™ 5.5 SPINAL SYSTEM Slide hammer ROD PUSHER ANAX™ 5.5 Spinal System Velofix Interbody Fusion System UniSpace® Stand-Alone C Cage ANAX 5.5 Spinal System Various Types of Covers Various Types of Trayes Various Types of Containers Various Types of Cases SURGICAL INSTRUMENT TRAY Screw gauge ROD FORK Perfix Spinal System ANAX OCT Spinal System ASPIRON ACP 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 Anax™ 5.5 MIS system Anax™ MIS system Dyna Locking Trochanteric Nail 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 Perfix Iliac Screw System

    Establishment Types

    Repack or Relabel Medical Device