BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    Genesis All Suture Anchor (JS type)

    Reg #: 3014232239 · FEI: 3014232239 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Aju Medical Co., Ltd.
    Registration Number
    3014232239
    FEI Number
    3014232239
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Room 201, Room 207, BL A, 697, Pangyo-ro, Bundang-gu
    City
    Seongnam-si Gyeonggi
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K222423

    Owner / Operator

    Firm Name
    AJU Medical Co., Ltd.
    Operator Number
    10056622
    Address
    Room 201, Room 207, BL A, 697, Pangyo-ro, Bundang-gu
    City
    Seongnam-si
    State
    Gyeonggi
    Postal Code
    13511
    Country
    KR

    Products

    Device Name Product Code
    Fastener, Fixation, Nondegradable, Soft Tissue MBI

    Proprietary Names

    Genesis All Suture Anchor (JS type) Fixone All Suture Anchor (J,JS,JM,JF type)

    Establishment Types

    Manufacture Medical Device