BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    The Prase MIS Spinal Fixaiton System

    Reg #: 3015136700 · FEI: 3015136700 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    GBS COMMONWEALTH, CO. LTD.
    Registration Number
    3015136700
    FEI Number
    3015136700
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    168 Gasan Digital 1-ro, Geumcheon-gu, 309, Woolim Lions Valley C
    City
    Seoul
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K190762

    Owner / Operator

    Firm Name
    GBS Commonwealth, Co. Ltd.
    Operator Number
    10059134
    Address
    168 Gasan Digital 1-ro, Geumcheon-gu, 309, Woolim Lions Valley C
    City
    Seoul
    State
    KR-11
    Postal Code
    08507
    Country
    KR

    US Agent

    Business Name
    PMT Republic
    Contact Name
    Kevin Ahn
    Address
    20616 truss ct
    City
    Walnut
    State
    CA
    ZIP
    91789
    Country
    US
    Email
    [email protected]
    Phone
    909 5201855

    Products

    Device Name Product Code
    Thoracolumbosacral Pedicle Screw System NKB

    Proprietary Names

    The Prase MIS Spinal Fixaiton System Jasper MIS Spinal System The Jasper Spinal Fixation System THE JASPER Spinal Fixation System II

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device