BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    GS MEDICAL CO., LTD.

    Reg #: 3005596514 · FEI: 3005596514 · Expires 2026
    View on FDA
    Products
    38
    Proprietary Names
    111
    Establishment Types
    1
    Classifications
    38

    Registration Details

    Registration Name
    GS MEDICAL CO., LTD.
    Registration Number
    3005596514
    FEI Number
    3005596514
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    90, Osongsaengmyeong 4-ro, Osong-eup,
    City
    Heungdeok-gu, Cheongju-si Chungbuk
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K200592

    Owner / Operator

    Firm Name
    GS Solutions, Inc.
    Operator Number
    9080979
    Address
    3210 S. Susan St. Santa Ana 92704
    City
    Santa Ana
    State
    CA
    Postal Code
    92704
    Country
    US

    US Agent

    Business Name
    GS SOLUTIONS, INC.
    Contact Name
    James Shin
    Address
    3210 S Susan St
    City
    Santa Ana
    State
    CA
    ZIP
    92704
    Country
    US
    Email
    [email protected]
    Phone
    949 3806385 ext. 163

    Products

    Device Name Product Code
    Driver, Surgical, Pin GFC
    Intervertebral Fusion Device With Bone Graft, Cervical ODP
    Retractor GAD
    Appliance, Fixation, Spinal Intervertebral Body KWQ
    Appliance, Fixation, Spinal Interlaminal KWP
    Thoracolumbosacral Pedicle Screw System NKB
    Awl HWJ
    Tray, Surgical, Instrument FSM
    Orthopedic Manual Surgical Instrument LXH
    Orthosis, Spinal Pedicle Fixation MNI
    Orthosis, Spondylolisthesis Spinal Fixation MNH
    Intervertebral Fusion Device With Bone Graft, Lumbar MAX
    Tap, Bone HWX
    Cement, Bone, Vertebroplasty NDN
    Arthroscope HRX
    Rasp HTR
    Bender HXW
    Guide, Needle, Surgical GDF
    Guide, Surgical, Instrument FZX
    Hammer, Surgical FZY
    Screwdriver HXX
    Stylet, Surgical, General & Plastic Surgery GAH
    Gauge, Depth HTJ
    Clamp HXD
    Rongeur HTX
    Intervertebral Fusion Device With Integrated Fixation, Cervical OVE
    Reamer HTO
    Wrench HXC
    Impactor HWA
    Instrument, Compression HWN
    Osteotome HWM
    Intervertebral Fusion Device With Integrated Fixation, Lumbar OVD
    Instrument, Cutting, Orthopedic HTZ
    Probe HXB
    Tamp HXG
    Curette HTF
    Forceps HTD
    Spinal Channeling Instrument, Vertebroplasty OCJ

    Proprietary Names

    Anyplus II T-Handle (Square) Scoli Set Screw Driver with I-Handle Driver Anyplus II Powerease Screw Driver Scoli Accessory Set Screw Final Driver Poly Quick Driver Anyplus Peek Cage System Retractor AnyPlus Spinal Fixation System (CoCr Rod) Anyplus II Navigation Awl Awl Anyplus II Awl PYXIS 3D Titanium Cervical Cage Instruments Tray Tray New Anyplus II Prebent Rod Caddy Anyplus II Implant Tray Anyplus II Instrument Tray (1/2) Universal Removal Set Tray Hex Male Quick Lock Trial Anyplus II Ball Tip Tester, Straight Scoli I-Ratchet Handle AnyPlus II Persuader Anyplus II Distractor OLIF II Tiral 3D OLIF II Thread Inserter Hex Female Rod Gripper Anyplus II Rod Holder 3D Cervical Cage 3D Printed Trial Hexalobe Male 3D Guide Inserter PULSAR Expandable PLIF Navigation Inserter Anyplus II Tab Breaker Navigation Fork Template Anyplus II Pediatric Rod Holder Anyplus II Rod Pusher (Straight Type) 3D Printed Expandable PLIF Trial 3D Cervical Cage Trial Anyplus II Ball Tip Tester, Curved Quasar Trial Without Stopper 3D Printed OLIF II Trial Anyplus Long Arm screw (Self, Conical) Dual AnyPlus Spinal Fixation System PYXIS 3D Titanium ALIF Cage PYXIS 3D Titanium Cage PYXIS 3D Titanium XTLIF Cage Anyplus II Navigation Tapper Anyplus II Navigation Longarm Tapper DL Nav Compatible Tap Tap Anyplus II Dual Lead Tap Anyplus II Powerease Tapper TRACKER Rasp Pulsar Expandable Cage System Anyplus II In-Situ Bender, Right Bender Anyplus II Rod Bender Anyplus II In-Situ Bender, Left Guide Wire Guide Hammer Anyplus II Navigation Poly Screw Driver Anyplus II Navigation Longarm Screw Driver Anyplus II Navigation Poly Reduction Screw Driver Anyplus II Set Screw Final Driver, 12N Scoli Crosslink Counter Torque Anyplus II Set Screw Starter, T-Type Anyplus II Cannulated Poly Screw Driver Anyplus II Cannulated Poly Reduction Screw Driver Anyplus II Set Screw Starter, Dual Anyplus II Head Adjuster Anyplus II Set Screw Driver, T-Handle stylet Gauge Clamp Rongeur Pituitary QUASAR Standalone ACIF System GSS Pedicle screw system Extended Crosslink Reamer Distractor Anyplus II Anti-Torque Wrench Wrench PYXIS 3D Cervical Titanium Cage System QUASAR 3D Titanium Standalone ACIF System Impactor Anyplus II Spianl Fixation System Tracker Plus Curved Kit Dispenser kit (Cement Dispenser Kit, Inflation Device, Cement Mixing System) AnyPlus® Cervical PEEK Cage System Compressor/Distractor - Vorzeigen Anyplus II Compressor Osteotome Anyplus PEEK Cage System ALIF AnyPLUS PEEK Lumbar Cages TLIF Cutting Trial AnyPLUS DLIF PEEK Lumbar Fusion Cage Quasar-IF Stand-alone ACIF Cage Anyplus II Navigation Probe Anyplus II Probe, Curved Anyplus II Probe, Straight Probe Tamp Curette Anyplus II Rod Rotation Forcep Forceps ACP Tracker VP Needle kit

    Establishment Types

    Manufacture Medical Device