BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    OPTIMUS CMF System

    Reg #: 3011530718 · FEI: 3011530718 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    OSTEONIC CO., LTD.
    Registration Number
    3011530718
    FEI Number
    3011530718
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    405,505-2,505-3,508,603,902,1004,1005,1103,1201,1202,1203,1204,1205,1206-Ho, 38, Digital-ro 29-gil, Guro-gu, 102, 103-Ho, 24, Digital-ro 27-gil, Guro-gu, 1012, 1013-Ho, 272, Digital-ro, Guro-gu
    City
    Seoul
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K140037

    Owner / Operator

    Firm Name
    OSTEONIC Co., Ltd.
    Operator Number
    10048673
    Address
    1004Ho,1206Ho,38, Digital-ro 29-gil, Guro-gu, 102Ho, 103Ho, 24, Digital-ro 27-gil, Guro-gu
    City
    Seoul
    State
    KR-NOTA
    Postal Code
    08381
    Country
    KR
    Correspondent
    Dong Won Lee

    Products

    Device Name Product Code
    Plate, Bone JEY
    Screw, Fixation, Intraosseous DZL

    Proprietary Names

    OPTIMUS CMF System

    Establishment Types

    Manufacture Medical Device