BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ANAX OCT Spinal System

    Reg #: 3009554293 · FEI: 3009554293 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    CG MedTech USA, Inc.
    Registration Number
    3009554293
    FEI Number
    3009554293
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    41 Corporate Park Suite 200
    City
    Irvine
    State
    CA
    ZIP
    92606
    Country
    US

    Regulatory Submissions

    510(k) Number
    K150570

    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

    Products

    Device Name Product Code
    Appliance, Fixation, Spinal Interlaminal KWP
    Posterior Cervical Screw System NKG

    Proprietary Names

    ANAX OCT Spinal System

    Establishment Types

    Repack or Relabel Medical Device