BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    Anax™ 5.5 MIS system

    Reg #: 9617297 · FEI: 3003200961 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    CG MedTech Co., Ltd.
    Registration Number
    9617297
    FEI Number
    3003200961
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    20, Sandan-ro 76beon-gil(Rd)
    City
    Uijeongbu-si Gyeonggi
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K162189

    Owner / Operator

    Firm Name
    CG MedTech Co., Ltd.
    Operator Number
    9045343
    Address
    20, Sandan-ro 76beon-gil(Rd)
    City
    Uijeongbu-si
    State
    Gyeonggi
    Postal Code
    11781
    Country
    KR

    US Agent

    Business Name
    Fortrea Inc.
    Contact Name
    Theresa Carlson
    Address
    8 Moore Drive
    City
    Durham
    State
    NC
    ZIP
    27709
    Country
    US
    Email
    [email protected]
    Phone
    651 2736891

    Products

    Device Name Product Code
    Orthosis, Spondylolisthesis Spinal Fixation MNH
    Orthosis, Spinal Pedicle Fixation MNI

    Proprietary Names

    Anax™ 5.5 MIS system Anax™ MIS system ANAX™ 5.5 Spinal System

    Establishment Types

    Manufacture Medical Device