BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    L3A.35061

    Reg #: 3011530718 · FEI: 3011530718 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    428
    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
    K243469

    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, Fixation, Bone HRS
    Screw, Fixation, Bone HWC

    Proprietary Names

    L3A.35061 G3F.50110 A3M.13100 G1F.35090 C6.35420 G3E.50080 S1B.35180 G1F.35020 S1B.35110 G3E.50030 G1C.35060 G3F.35160 G1F.35100 S1B.35160 L4B.50080 G3F.35130 C5.35100 S1B.50650 C6.35190 C5.35120 G1C.35070 C7.37420 S1B.35120 C7.30320 S1B.35540 L3A.35101 L2A.35120 S1B.35550 S1B.35600 B1D.22040 C5.35220 G1C.35040 S1B.35240 J2G.35041 S1B.50450 S1B.35420 G3F.35150 C6.35150 G3F.35020 C7.30480 S1B.35450 G3F.50140 G1C.35050 L4A.35091 L3A.35011 C6.35180 L4A.35031 C6.35620 G1F.35110 L4B.50140 B1D.22020 B1D.22030 A3A.13040 G3E.35060 A1H6080 G3E.50010 L3A.35041 S1B.50180 C6.35500 G3E.35020 L2A.35130 L4A.35191 G1F.35130 C7.30360 K1E.50130 S1B.35220 L4A.35021 L4A.35141 L4C.50120 G1C.35100 G1C.35010 B2B.35031 B1D.22010 C5.35200 G3E.35050 G3E.35100 K1E.50010 C7.37440 K1E.50080 J2G.35051 C5.35400 S1B.35130 C7.30200 C6.35280 L4C.50140 K1E.50070 S1B.35320 L4C.50160 C7.30400 C6.35240 G1F.35030 B1D.25030 G3F.50120 L4C.50010 G3E.35130 G3E.35010 L4C.50030 A1J6080 G3F.50160 A3C.13100 L4A.35081 C5.35340 J2G.35022 S1B.35190 L4C.50080 A3A.13080 S1B.50280 C7.37400 L4B.50110 B2A.35022 G1F.35080 G3E.50120 G3F.50030 A1R6010 G3F.35060 G3F.35170 L4B.50160 A3N.13100 S1B.35150 L3A.35081 A1A6120 C7.24160 S1B.35750 G3E.35110 S1B.35400 B2B.35041 C7.37380 G3E.50160 A1J6060 G1C.35090 G3F.35040 G3F.50070 S3F.45400 G3F.35140 G3E.35160 C5.35450 S1B.50360 A1G6060 B2B.35051 G3F.50180 C7.30460 B2B.35081 A1K6060 C7.24260 C7.30240 L3A.35021 G3E.50090 C6.35110 S1B.50750 S3F.45220 B2A.35081 G1F.35070 K1E.50040 B2A.35011 K1E.50110 C5.35160 G1C.35020 L2A.35160 B1D.25020 L4B.50060 S1B.35520 S1B.35360 S1B.50220 C6.35460 L4C.50150 C6.35160 C7.30340 C7.30180 B2B.35011 S1B.50700 G1F.35150 S3F.45280 G3F.35070 C7.37540 S3F.45200 L4B.50030 L4B.50040 S1B.35300 C6.35450 C5.35380 C6.35260 C7.24140 G1F.35120 C6.35130 L2A.35170 S1B.35480 C5.35130 C6.35170 S1B.50160 S1B.50600 C7.24240 S3F.45360 L4B.50070 S1B.50140 G3E.50110 S1B.35460 C6.35120 C7.30260 J2G.35011 G3F.50010 S1B.50850 L4C.50020 C7.37580 C5.35320 C7.37340 S3F.45420 C6.35540 C7.30140 S1B.35100 A1G6100 L4C.50090 B1D.25040 C7.30440 L4A.35041 L4A.35051 C7.30500 C6.35560 S1B.35280 C7.37460 C6.35550 L2A.35110 S1B.35500 L4A.35131 S1B.50800 K2E.50010 S1B.50340 S1B.35650 S1B.35700 K1E.50050 C6.35320 C5.35600 S1B.35440 C6.35380 L4A.35011 G3E.50040 C7.37520 C7.24280 G3E.35150 G3E.35040 J2G.35012 S3F.45300 G3E.35090 S3F.45540 S1B.50480 C5.35190 C6.35480 C6.35100 K1E.50140 L4B.50130 S3F.45240 C7.30220 G1F.35010 B1D.29020 L4C.50070 S1B.50240 L4B.50050 G3E.35070 L4B.50150 C7.24180 C7.30160 L4A.35171 L4B.50020 S1B.50300 G3E.50070 L3A.35071 G3F.35010 S1B.35340 L4C.50060 B2A.35061 G3E.35120 K2E.50020 L2A.35150 S1B.35380 B2B.35021 G3E.50050 G3F.35030 S1B.35560 L3A.35111 C5.35180 S3F.45320 G3F.35110 C5.35240 S1B.50500 A1A6040 C5.35140 B2A.35012 G1F.35060 L3A.35121 L4B.50120 K1E.50090 B2B.35061 C7.37320 L4B.50100 G3F.50080 C6.35220 C5.35360 K2E.50030 C6.35580 G3F.50100 C6.35200 C6.35440 C6.35600 J2G.35081 B2A.35031 C6.35360 C5.35110 B2B.35071 C6.35340 A1H6060 S1B.50460 S3F.45460 S1B.50320 S1B.50550 S3F.45520 S1B.35200 K1E.50100 S3F.45260 G3F.35120 K1E.50120 S1B.35800 G3F.35180 G3F.35100 G1F.35050 L4A.35151 J2G.35031 G3F.50060 L4B.50010 C5.35150 G3E.50060 C7.37500 L4C.50180 K1E.50060 L4C.50110 G3E.50130 G3F.50150 L4C.50130 B2A.35071 S3F.45580 C5.35260 L4A.35181 G1C.35080 G3F.50040 C6.35140 G3F.50170 C7.24200 C5.35500 G3E.50140 G1F.35160 G1F.35040 C5.35300 L3A.35051 G3E.35030 B2A.35021 C5.35280 S1B.50420 S3F.45380 S1B.50400 J2G.35021 C7.30300 L2A.35140 G3F.35050 C7.30280 J2G.35071 L4A.35101 L4A.35071 C5.35170 B1D.25010 G3F.50020 C7.37560 C7.30380 G3E.50020 C7.37300 G3F.50130 S3F.45500 C5.35550 G3E.50100 L4A.35111 L4C.50040 C6.35400 G3F.35080 C7.30420 G3E.35080 C7.24220 S1B.50900 B1D.29010 C7.37360 L4C.50170 G3F.50050 S1B.35170 A1C6070 G1F.35140 K1E.50030 S3F.45340 G3F.50090 S1B.50200 S1B.35140 S1B.50440 C6.35300 L4C.50050 S1B.50380 S1B.35580 L4A.35121 S3F.45600 S3F.45440 L3A.35031 K1E.50020 G3E.35140 S1B.35260 J2G.35061 S3F.45480 S1B.50260 B2A.35041 B2A.35051 A1L6060 L4C.50100 C6.35520 A1E6070 L4B.50090 C7.37480 L4A.35061 G1C.35030 G3F.35090 S1B.35620 C7.37600 L3A.35091 S3F.45560 G3E.50150 L4A.35161

    Establishment Types

    Manufacture Medical Device