BEUDAMED
    FDA Registration Active 🇹🇭 Thailand

    G Surgical Marksman System

    Reg #: 3006378738 · FEI: 3006378738 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    G SURGICAL CO., LTD.
    Registration Number
    3006378738
    FEI Number
    3006378738
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    294/62 Nalin Avenue, Ramkamhaeng Road, SAPANSUNG
    City
    BANGKOK Krung Thep Maha Nakhon
    Country
    TH

    Regulatory Submissions

    510(k) Number
    K193219

    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
    Correspondent
    DONALD - GRAFTON

    US Agent

    Business Name
    G Surgical CO., LTD
    Contact Name
    Donald Grafton
    Address
    9433 Bee Cave Rd Bldg 3 Ste 101-A
    City
    Austin
    State
    TX
    ZIP
    78733
    Country
    US
    Email
    [email protected]
    Phone
    512 4944749

    Products

    Device Name Product Code
    Thoracolumbosacral Pedicle Screw System NKB

    Proprietary Names

    G Surgical Marksman System

    Establishment Types

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