BEUDAMED
    FDA Registration Active 🇺🇸 United States

    G Surgical Marksman MIS System

    Reg #: 3009169872 · FEI: 3009169872 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    3
    Classifications
    3

    Registration Details

    Registration Name
    G Surgical LLC
    Registration Number
    3009169872
    FEI Number
    3009169872
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    9433 Bee Cave Road, Building 3, Suite 101-A
    City
    Austin
    State
    TX
    ZIP
    78733
    Country
    US

    Regulatory Submissions

    510(k) Number
    K161516

    Owner / Operator

    Firm Name
    G SURGICAL LLC
    Operator Number
    9096480
    Address
    9433 Bee Cave Road, Building 3, Suite 101-A
    City
    Austin
    State
    TX
    Postal Code
    78733
    Country
    US

    Products

    Device Name Product Code
    Orthosis, Spondylolisthesis Spinal Fixation MNH
    Orthosis, Spinal Pedicle Fixation MNI
    Thoracolumbosacral Pedicle Screw System NKB

    Proprietary Names

    G Surgical Marksman MIS System

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device