BEUDAMED
    FDA Registration Active 🇺🇸 United States

    GAUTHIER BIOMEDICAL, INC.

    Reg #: 2134947 · FEI: 3010938185 · Expires 2026
    View on FDA
    Products
    51
    Proprietary Names
    0
    Establishment Types
    2
    Classifications
    51

    Registration Details

    Registration Name
    GAUTHIER BIOMEDICAL, INC.
    Registration Number
    2134947
    FEI Number
    3010938185
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    2221 Washington St
    City
    Grafton
    State
    WI
    ZIP
    53024
    Country
    US

    Owner / Operator

    Firm Name
    GAUTHIER BIOMEDICAL, INC.
    Operator Number
    9041205
    Address
    2221 Washington Street
    City
    Grafton
    State
    WI
    Postal Code
    53024
    Country
    US

    Products

    Device Name Product Code
    Probe HXB
    Bender HXW
    Intervertebral Fusion Device With Bone Graft, Cervical ODP
    Spinal Vertebral Body Replacement Device MQP
    Intervertebral Fusion Device With Bone Graft, Lumbar MAX
    Tamp HXG
    Thoracolumbosacral Pedicle Screw System NKB
    Impactor HWA
    Appliance, Fixation, Spinal Intervertebral Body KWQ
    Driver, Surgical, Pin GFC
    Plate, Fixation, Bone HRS
    Screw, Fixation, Bone HWC
    Instrument, Compression HWN
    Rod, Fixation, Intramedullary And Accessories HSB
    Instrument, Cutting, Orthopedic HTZ
    Driver, Prosthesis HWR
    Appliance, Fixation, Spinal Interlaminal KWP
    Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite LXT
    Orthopedic Stereotaxic Instrument OLO
    Template HWT
    Instrument, Manual, Surgical, General Use MDM
    Extractor HWB
    Bit, Drill HTW
    Hammer, Surgical FZY
    Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component KTT
    Device, Fixation, Proximal Femoral, Implant JDO
    Orthosis, Spinal Pedicle Fixation MNI
    Orthosis, Spondylolisthesis Spinal Fixation MNH
    Awl HWJ
    Osteotome HWM
    Stimulator, Nerve ETN
    Orthopedic Manual Surgical Instrument LXH
    Pusher, Socket HXO
    Rasp HTR
    Guide, Surgical, Instrument FZX
    Wrench HXC
    Retractor GAD
    Sacroiliac Joint Fixation OUR
    Neurological Stereotaxic Instrument HAW
    Mallet HXL
    Instrument, Surgical, Non-Powered HAO
    Screwdriver HXX
    Gauge, Depth HTJ
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer JWH
    Drills, Burrs, Trephines & Accessories (Simple, Powered) HBE
    Prosthesis, Elbow, Hemi-, Radial, Polymer KWI
    Handle, Scalpel GDZ
    Curette HTF
    Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis OSH
    Clamp, Surgical, General & Plastic Surgery GDJ
    Pin, Fixation, Threaded JDW

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device