BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    COLONNADE Posterior Screw Fixation System

    Reg #: 3017036472 · FEI: 3017036472 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    CG BIO CO., LTD.
    Registration Number
    3017036472
    FEI Number
    3017036472
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    B1, 1F, 2F, C-dong, 29, Jeyakdanji-ro, Hyangnam-eup
    City
    Hwaseong-si Gyeonggi
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K250582

    Owner / Operator

    Firm Name
    CG Bio Co., Ltd.
    Operator Number
    10040923
    Address
    3rd floor, Hannam Bd.211, Itaewon-ro,
    City
    Yongsan-Gu
    State
    Seoul
    Postal Code
    04349
    Country
    KR
    Correspondent
    Suwon Lee

    Products

    Device Name Product Code
    Thoracolumbosacral Pedicle Screw System NKB

    Proprietary Names

    COLONNADE Posterior Screw Fixation System

    Establishment Types

    Manufacture Medical Device