BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    110047688

    Reg #: 3011530718 · FEI: 3011530718 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    43
    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
    K231326

    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
    Fastener, Fixation, Biodegradable, Soft Tissue MAI

    Proprietary Names

    110047688 BIS-2610-2840 BHA-4816-1310 BIS-2110-2840 110047690 BLA-4750-1910 110047691 Fix2Lock(Biocomposite medial, Biocomposite lateral, Biocombi Self Punching) BHA-4816-2200 BHD-5021-1030 BHA-4816-3550 110047693 BHA-4816-3490 BSA-2110-274N2 110047689 BPL-4750-1910 110047663 BHA-4816-2180 BHD-4521-1030 BSA-2110-172N 110047675 BHA-4816-2380 BIS-2610-1820 BHA-4816-3240 BIS-2110-1820 BLA-4722-1910 110047694 BIN-2612-2180 BIN-2612-2200 BIN-2612-1130 BIN-2612-1720 BIN-2612-2740 BSA-2110-172N2 BPD-4750-1030 BIN-2612-1820 110047673 110047692 BHA-4816-2520 BPH-4521-1910 BIN-2612-2840 110047674 BPH-5021-1910 BSA-2110-274N

    Establishment Types

    Manufacture Medical Device