BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    Fix2Lock(Biocomposite medial, Biocomposite lateral, Biocombi Self Punching)

    Reg #: 3011530718 · FEI: 3011530718 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    233
    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
    K202806

    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, Biodegradable, Soft Tissue MAI
    Fastener, Fixation, Nondegradable, Soft Tissue MBI

    Proprietary Names

    Fix2Lock(Biocomposite medial, Biocomposite lateral, Biocombi Self Punching) BMA-4518-3220 BMA-4518-1310 BMA-4518-3540 BMA-5519-3480 BHA-4820-3430 BHA-5819-2330 BLA-4750-BC225-1 BHA-5819-2150 BHA-6520-2190 BHA-5320-3550 BHA-6520-3450 BIS-2110-1710 110047678 BHA-5320-3230 BHA-5320-2520 BHA-6520-3430 BPH-5021-1120 110047680 BMA-5519-2200 BMA-5519-2370 BHA-4820-2330 BHA-4820-3550 BHA-5819-3450 BIS-2110-1720 BLA-4722-1120 BMA-4518-2330 BMA-4518-3550 BMA-5519-3490 BHA-4820-3440 BHA-5819-2340 BLA-47-21A BPL-4750-1140 BMA-4518-2360 BMA-5519-3550 BHA-4820-3480 BHA-5320-3440 BHA-5819-2370 BHA-6520-2340 BLA-4750-1130 BPH-4521-1110 110045267 BHA-4820-3240 BHA-5320-2360 BHA-5819-3550 BHA-6520-3490 BPL-4750-1130 110047704 BHA-4820-2170 BHA-5320-3210 BHA-5320-3480 BHA-5819-3440 BHA-6520-2370 BPH-4521-1140 110047682 BHA-4820-3230 BHA-5320-2350 BHA-5819-3540 BPL-4750-1120 110047705 BMA-5519-3440 BHA-4820-3210 BHA-5320-2330 BHA-5819-3490 BPL-4750-1030 BPH-5021-1140 BMA-4518-2190 BMA-5519-3230 BMA-4518-3480 BHA-6520-2160 BHA-4820-2360 BIS-2110-2180 BIS-2610-1720 BMA-4518-2340 BMA-5519-1300 BMA-5519-2520 BHA-4820-3450 BHA-5320-2380 BHA-5819-2350 BLA-4750-1110 BPH-4521-1030 BMA-4518-2200 BMA-5519-3240 BMA-4518-3490 BHA-6520-2170 BHA-4820-2370 BHA-5819-1300 BIS-2110-2190 BIS-2610-1730 BMA-4518-2370 BHA-4820-2150 BHA-5320-2190 BHA-4820-3490 BHA-5320-3450 BHA-5819-2380 BHA-6520-2350 BPH-4521-1120 110045265 BHA-5320-2160 BHA-5819-2200 BHA-6520-1310 BHA-6520-3540 110047687 BMA-4518-2380 BHA-4820-2160 BHA-5320-2200 BHA-5320-3460 BHA-5819-3430 BHA-6520-2360 BPH-4521-1130 110045263 BMA-4518-2160 BMA-4518-3440 BHA-5819-3230 BIS-2110-1120 110047684 BHA-5320-3240 BHA-5320-3540 BHA-6520-3440 BIS-2110-2200 BPH-5021-1130 110047679 BHA-4820-2180 BHA-5320-3220 BHA-5320-3490 BHA-6520-2380 BPH-5021-1110 110047681 BHA-5320-2150 BHA-5819-2190 BHA-5320-2370 BHA-6520-1300 BHA-6520-2520 110047703 BMA-4518-3240 BHA-5819-2170 BHA-6520-3210 BHA-6520-3480 BIS-2610-1130 110047676 BMA-5519-3220 BMA-5519-3430 BHA-4820-2200 BHA-5320-1310 BHA-5819-3480 BLA-4722-1140 BMA-4518-2350 BMA-5519-3540 BHA-4820-3460 BHA-5320-3430 BHA-5819-2360 BLA-4750-1120 BPH-5021-1030 110045269 BMA-5519-2180 BMA-5519-2350 BHA-4820-1300 BHA-4820-2520 BIS-2610-2200 BLA-4722-1030 BMA-5519-2190 BMA-5519-2360 BHA-4820-1310 BHA-4820-3540 BIS-2610-1710 BLA-4722-1110 BMA-5519-2150 BMA-5519-1310 BHA-5819-2180 BHA-6520-3220 BIS-2610-1140 110047664 BMA-4518-3230 BHA-5819-2160 BHA-6520-2200 BHA-6520-3460 BIS-2610-1120 110047677 BMA-5519-2160 BMA-5519-2330 BHA-6520-3230 BIS-2610-2180 110045289 BMA-5519-3210 BMA-5519-2380 BHA-4820-2190 BHA-4820-2340 BHA-5320-1300 BHA-5819-3460 BLA-4722-1130 BMA-5519-2170 BMA-5519-2340 BHA-6520-3240 BIS-2610-2190 BLA-4750-1140 110045282 BMA-4518-2180 BMA-4518-3460 BHA-6520-2150 BHA-4820-2350 BIS-2110-1140 BIS-2110-2740 BHA-5320-2170 BHA-5819-3210 BHA-6520-2330 BHA-6520-3550 110047686 BMA-4518-3210 BMA-4518-1300 BMA-4518-2520 BMA-5519-3460 BHA-6520-2180 BHA-4820-2380 BHA-5819-1310 BIS-2610-2740 BMA-5519-3450 BHA-4820-3220 BHA-5320-2340 BHA-5819-2520 BPL-4750-1110 110047706 BMA-4518-2150 BMA-4518-3430 BHA-5320-2180 BHA-5819-3220 BHA-6520-3900 110047685 BMA-4518-2170 BMA-4518-3450 BHA-5819-3240 BIS-2110-1130 BIS-2110-1730 110047683

    Establishment Types

    Manufacture Medical Device