BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    A8.2304

    Reg #: 3011530718 · FEI: 3011530718 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    96
    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

    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
    Bit, Drill HTW

    Proprietary Names

    A8.2304 B1P.3101 B1P.3201 Y7A.30010 Y1A.38020 650DRILL Y1A.43020 Y1A.43010 375DRILL D8P.31210 Y1A.45020 550DRILL C8P.31230 Y1A.30020 Y1A.37010 Y1A.22020 Y1A.21010 Y1A.25020 C8P.31200 Optimus CMF System - Trocar set (various models) Optimus CMF System - Surgical drill bit-non power (various models) Optimus CMF System - Drill guide (various models) FDB-17 FDB-01 MDB-02 IOC-091 FDB-18 ODB-09 FDB-04 MDB-08 FDB-11 ODB-13 MDB-07 ODB-07 FDB-14 MDB-05 ODB-08 FDB-15 FDB-19 ODB-01 IOC-161 ODB-04 MDB-01 IOC-092 FDB-03 MDB-04 NDB-01 FDB-05 ODB-15 FDB-20 FDB-09 ODB-11 BIS-2110-DR A8.2302 IOC-093 FDB-06 FDB-10 ODB-12 BIS-2610-DR Y1A.24020 Y1A.35010 Y1A.18010 FDB-02 MDB-03 MDB-09 Y1A.28020 Y1A.22010 Y7A.43010 IOC-094 FDB-07 IOC-151 ODB-02 ODB-06 FDB-13 IOC-150 IOC-095 FDB-08 ODB-10 FDB-16 MDB-06 ODB-14 Y7A.32010 Y1A.30010 IOC-160 ODB-03 ODB-05 FDB-12 475DRILL Y1A.28010 110045296 110045297 NDB-02 D8P.31170 A8.2301 Y1A.32010 Y1A.35020

    Establishment Types

    Manufacture Medical Device