BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    EDEN Spinal Fixation MIS System

    Reg #: 3021006165 · FEI: 3021006165 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    JMT CO., LTD.
    Registration Number
    3021006165
    FEI Number
    3021006165
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    70-39, Gwonyul-ro 1203beon-gil, Baekseok-eup
    City
    Yangju-si Gyeonggi
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K230762

    Owner / Operator

    Firm Name
    JMT Co., Ltd.
    Operator Number
    10083217
    Address
    70-39, Gwonyul-ro 1203beon-gil, Baekseok-eup
    City
    Yangju-si
    State
    Gyeonggi
    Postal Code
    11517
    Country
    KR
    Correspondent
    Sang-Ok Nam

    US Agent

    Business Name
    LK Consulting Group USA, Inc.
    Contact Name
    Priscilla Chung
    Address
    18881 Von Karman Ave STE 160
    City
    Irvine
    State
    CA
    ZIP
    92612
    Country
    US
    Email
    [email protected]
    Phone
    714 2025789

    Products

    Device Name Product Code
    Thoracolumbosacral Pedicle Screw System NKB

    Proprietary Names

    EDEN Spinal Fixation MIS System

    Establishment Types

    Manufacture Medical Device