BEUDAMED
    FDA Registration Active 🇺🇸 United States

    GS Solutions, Inc.

    Reg #: 3008850074 · FEI: 3008850074 · Expires 2026
    View on FDA
    Products
    34
    Proprietary Names
    72
    Establishment Types
    1
    Classifications
    34

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    Registration Details

    Registration Name
    GS Solutions, Inc.
    Registration Number
    3008850074
    FEI Number
    3008850074
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    3210 S Susan St
    City
    Santa Ana
    State
    CA
    ZIP
    92704
    Country
    US

    Regulatory Submissions

    510(k) Number
    K100516

    Owner / Operator

    Firm Name
    GS Solutions, Inc.
    Operator Number
    10035190
    Address
    3210 S Susan St
    City
    Santa Ana
    State
    CA
    Postal Code
    92704
    Country
    US
    Correspondent
    James (Hanjin) Shin

    Products

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

    Proprietary Names

    Screw System Cutting Forceps Sharp Guide wire - disp. instr. Blunt Guide wire - Disp. Instr. Target Needle - sterile Target Needle - MPM Impactor, Lumbar Impactor, Cervical Disc Shaver Cutting Trial Rod Length Gauge - Vorzeigen AnyPlus PEEK Lumbar Cages PYXIS 3D Titanium Cervical Cage System In situ Rod Bender, left/right - SIMS Coronal Bender, left/right - In'Tech Screw System Rod Clamp Pituitary, Posterior GSS Pedicle Screw System Shavers - SIMS MIS compressor/distractor - Vorzeigen compressor - PAK AnyPlus Implant Case GSS Implant Case AnyPlus Instrument Case Pedicle Standard Instrument Case GSS Instrument Case Obturator stylet AnyPlus Spinal Fixation System QUASAR Standalone ACIF Cage System Quasar Standalone ACIF Cage Guidewire drive with striker plate - Lowell Guidewire driver - Lowell Straight Osteotome Curved Osteotome AnyPlus Cervical PEEK Cage System AnyPlus PEEK Lumbar Fusion Cage Rasp, Straight Rasp, Curved Lumbar Cage Tamp Retractor holder set - Vorzeigen Soft Tissue Retractor - PAK Bifid Retractor - PAK Deflection Beam Torque Wrench - Gauthier GSS Counter Torque - SIMS Polyaxial locking driver - PAK AnyPlus PEEK Lumbar Fusion Cages Adapters Rod Reducer - Vorzeigen Distractor - PAK Shaft - In'Tech Rocker - In'Tech Torque Stabilizer - Vorzeigen EMG Sleeve - varied Handles, Straight and T - varied Tower - Lowell Wanding Blade - Vorzeigen Dilator - varied Pentalobe Tip - Teleflex Tapered wire probe - Lenox Bone Probe - Gauthier Bone Probe - Bradshaw Bone Tap - Vorzeigen Bone Tap - SIMS Lumbar Cage Slap Hammer Set Screwdriver - Lowell Set Screwdriver - Vorzeigen Curette, Cup Curette, Ring Awl and Tap combo - Huron Bone Awl - Gauthier Cannulated Awl - Vorzeigen Pulsar Expandable Cage Pulsar Expandable Cage System

    Establishment Types

    Repack or Relabel Medical Device