BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    PHD-5521-1130

    Reg #: 3011530718 · FEI: 3011530718 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    40
    Establishment Types
    1
    Classifications
    1

    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
    K231322

    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
    Fastener, Fixation, Nondegradable, Soft Tissue MBI

    Proprietary Names

    PHD-5521-1130 PHA-4816-3490 PHD-4521-1130 110047697 PSA-1808-172N 110047669 PSA-1808-274N2 110047672 110047671 110047667 110047701 PHA-4816-3240 PLD-5521-1130 PSA-1808-274N 110047666 PHA-4816-1310 PHL-5521-1910 110047670 Fix2Lock(PEEK Self Punching) PHA-4816-2380 PHA-4816-3550 110047698 PSA-1808-172N2 110047668 PHL-4521-1910 110047699 PHD-4521-1030 110047695 PLA-4521-1910 PHA-4816-2520 PLD-4521-1030 110047700 PLD-4521-1130 110047696 PHA-4816-2200 PLD-5521-1030 PHD-5521-1030 110047665 PHA-4816-2180 PLA-5521-1910

    Establishment Types

    Manufacture Medical Device