BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    Perfix Iliac Screw System

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

    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
    K132218

    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, Spinal Pedicle Fixation MNI
    Orthosis, Spondylolisthesis Spinal Fixation MNH
    Appliance, Fixation, Spinal Interlaminal KWP

    Proprietary Names

    Perfix Iliac Screw System

    Establishment Types

    Manufacture Medical Device