BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    SIGNEX

    Reg #: 3011530718 · FEI: 3011530718 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    928
    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
    K230546

    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
    Screw, Fixation, Bone HWC
    Plate, Fixation, Bone HRS

    Proprietary Names

    SIGNEX A5.20080 G1H.50010 S3H.50700 S3B.50500 H1E.35130 C6.28130 D1D.22170 S3B.35220 S1F.35650 S1H.50650 B1G.24180 S1D.35120 S1E.50650 B1G.24280 S1C.45400 A5.23060 A2A.10040 A5.13110 S1F.35180 B1B.24070 C6.28420 S1F.35360 A6.15150 B1B.27020 A6.20280 S1C.45460 A2M.13100 D1D.22140 A5.15070 S1B.28440 A5.23180 S1B.28140 C2A.16040 A6.23100 S1H.37340 S1D.28140 E2A.35140 S3B.50260 D2E.30180 S3B.35240 E2A.35250 S1H.50135 S1C.45105 A2A.13050 F1E.35140 D1D.22120 A5.25090 A5.25130 E2A.35260 C6.28380 H1D.35140 D1E.22240 S1D.35520 H1D.35080 S3B.35120 B2A.35061 D1D.22110 S1D.35260 S3H.50380 S1B.28660 S1F.35750 E1A.35040 S3H.50200 A6.20070 S1D.28440 D2E.30500 C1D.16340 A6.20200 S1D.35420 S1B.28560 S1B.28260 D2D.30450 S3H.50260 A6.15070 A5.15080 S3H.50600 A5.15200 S1H.37500 C6.28400 H1E.35050 A5.13060 A6.20150 C5.28140 E1G.35020 A2G8100 S1E.50850 A5.20140 C5.28400 S1D.28550 B1B.24080 S3H.50500 B1J.27090 S1F.35300 A6.15090 J3D.28020 A5.15060 S1F.35160 B1B.22080 S1D.35200 S1D.28420 A6.23200 B1B.22060 S1H.37800 D2E.30210 S1H.50120 S1F.35380 S1H.37725 A5.25080 S1H.50550 S1D.28110 S1H.37825 S1D.35280 F1E.35040 B1J.27150 K1H.50020 C6.28260 S1B.28100 S1H.37675 S1B.28320 S1H.37380 S1E.50100 A5.20130 S1H.37400 S1H.37640 C6.28200 S1C.45660 D2E.30280 S1D.35460 A5.15140 D2E.30170 D2E.30340 S1C.45500 C5.28320 B3A.20030 A2L8060 F1E.35020 C1D.16390 B1J.27200 B1G.24121 B2B.35021 C7.24240 D2D.30200 B1B.22030 B1G.24201 H1D.35110 S1H.37660 D2D.30210 S1H.37550 A6.15110 C5.28130 C7.37340 S3B.50360 S1H.37575 S1B.28520 B1B.28020 S1E.50105 C1A.13270 H1E.35070 S1H.37375 A2S.10070 B1B.22070 A6.23060 S1D.28540 C5.28120 S1D.28260 S1D.35340 J3D.28070 D1D.22260 B1B.24100 F1E.35120 C7.24280 A2C8060 S1C.45640 D2E.30300 C1B.16470 B1J.27280 S3B.35360 C6.28140 S3B.50380 A6.20060 F1E.35090 D2D.30220 B1G.24200 S1B.28700 A5.23090 A6.15100 S1H.37525 B2B.35071 H1E.35150 A2A8060 E1A.35010 S3H.50480 H1E.35040 B2B.35061 S3B.35260 C1A.13490 S1H.50900 B1B.24090 S1C.45420 B1G.24130 S3H.50320 S1B.28110 S3B.35340 E1G.35180 S1C.45220 S1H.50140 S1D.28480 D2D.30240 A2N.13060 A2A8120 J1B.24010 S1F.35100 D1D.22150 A2D.10090 A5.23140 A5.20060 A6.15140 S1H.37450 D1E.22300 S1F.35440 A5.23100 H3E.35020 F1E.35050 H1D.35030 D2D.30260 S1B.28220 S1D.28150 B1J.27140 S3H.50340 A5.23280 C1A.13380 A5.25120 B1G.24160 A6.15120 C7.37440 A5.13120 S3B.35460 S3H.50440 B1G.24240 C6.28300 S1F.35600 B1G.24221 S3H.50800 S1B.28450 A6.20160 S1H.37720 J3D.28040 B2B.35081 A6.20080 D2D.30100 S3B.50700 A5.23150 H1E.35010 A5.23300 H3E.35070 S3B.35420 J3D.28010 S1D.28340 A5.13100 D2E.30250 A5.15130 A5.18060 C7.37460 K1H.50030 S1C.45280 D1E.22340 S1D.35100 C7.37360 C7.24260 S1F.35560 B1B.23010 C6.28180 A5.15100 S1C.45550 S1B.28540 B1G.24300 E2A.35160 S1E.50700 S1B.28180 C5.28340 S1H.37850 S3B.50200 A5.20110 S1F.35580 S1F.35320 S1D.35600 A5.15090 A5.18100 C7.37500 S1F.35540 S1B.28640 A6.15200 B2B.35041 B1B.24040 H3E.35060 C7.37420 S1H.50350 A5.25070 S1H.50450 G3H.50030 F1E.35160 S1E.50900 D1E.22220 A6.20190 C5.28100 A6.20100 S1B.28460 D2D.30150 H3E.35050 E2A.35210 S3B.35140 A6.20260 H1D.35020 A2C.10070 S3B.35200 A5.13140 A5.20170 A6.20180 F1E.35010 C6.28240 S3H.50240 H3E.35040 B1B.28060 A5.20260 S1F.35200 C7.37560 B1J.27170 S1H.50600 A5.15160 S1F.35400 H1D.35060 S1F.35550 S3H.50360 E1G.35090 B1G.24141 A6.20300 A5.25140 C7.24180 S1C.45540 C6.28320 E1A.35030 H1E.35020 S1C.45750 A5.23200 C1A.16400 E1A.35110 S1B.28680 S1H.37775 B1B.28100 D1E.22380 D2D.30170 S1H.37540 S3B.50750 D1D.22180 S1H.37360 S1E.50450 S3B.50650 F1E.35070 C6.28280 C2A.13030 S1E.50550 H1D.35100 S1H.37750 E1G.35160 A6.20110 S3H.50400 A5.18120 D2D.30160 S1E.50110 A6.23130 S1D.35380 S1H.50950 A6.23070 A5.18110 S1H.37475 A6.23180 A5.23080 C2A.13060 D1D.22160 S1H.50750 B1G.24190 C6.28360 S1H.50400 D1D.22240 S1C.45240 A6.15080 A5.13080 B1G.24140 S1F.35340 C6.28450 D2E.30200 S1F.35240 H1D.35070 S1D.35360 A5.15170 A2U8090 D1D.22250 S1H.50130 G1H.50020 S1D.35440 A2D8110 C5.28240 D1D.22100 S3H.50280 A2G.10060 A5.23260 S1D.35800 S3B.35380 B2B.35031 D2E.30400 J3D.28030 E2A.35230 A6.15190 S1H.37875 S1H.37650 S1B.28120 S1H.37625 S1B.28340 B1G.24181 B1G.24220 S1D.28500 S1H.50800 A5.23190 S1H.37700 C7.37320 A5.15190 S1B.28130 A2K8060 S1D.35500 S1H.37350 D1D.22290 J3D.28080 A2J8060 A5.20240 A2M.13060 C6.28170 S1D.35300 B1J.27180 S1D.35150 S3H.50550 G3H.50040 S3B.50240 J1G.24030 E1G.35060 S3B.50600 S1D.35400 F1E.35080 C2A.13020 C1B.13320 A2U.13090 A5.18070 D2D.30400 E1G.35120 S1C.45700 S1C.45200 A2J8080 S1D.28560 J1G.24020 C7.24140 S1H.37740 D2D.30180 A5.20120 A2U.10090 S1F.35450 E1G.35070 B1B.28010 B1B.22050 S1C.45560 D2D.30250 S3B.50300 D1D.22130 S1D.28460 S1F.35670 C7.37600 S1F.35500 C2A.16050 S1D.28400 D1E.22280 A5.13070 A6.15170 S1C.45850 S3B.50550 E1A.35090 S1D.35480 S1D.28170 C5.28280 D2E.30230 S3B.50460 S1D.28220 E1A.35060 H3E.35030 A6.20090 C7.24220 C5.28360 C5.28110 B1J.27260 B1G.24110 A2H.13060 A2A8040 A2T.13100 E1A.35070 S1D.28640 C5.28260 D2D.30360 A5.20280 S1D.28380 J3D.28060 S1H.50100 C1C.13300 S1H.37760 D1D.22200 C6.28190 D1D.22270 B1J.27120 S1D.35130 S1H.37300 A2J.10060 B1J.27220 S1H.50250 C2A.13050 S1D.35170 S1H.37325 E1G.35100 C5.28180 S1C.45340 B1J.27130 J3D.28090 S1H.37420 B1B.27010 S3H.50300 C6.28440 D1D.22230 C2A.16030 H1E.35120 D2E.30320 D2D.30300 S1D.28600 S1C.45680 S3H.50750 A6.20170 S1D.28620 H1E.35200 H1D.35040 A5.23220 S1F.35280 A6.23190 C5.28380 A6.20130 S1H.37520 S1B.28400 S1B.28190 S3H.50460 D1E.22400 E1A.35120 A5.23160 D1E.22260 E2A.35220 S1B.28150 A2J.13060 C1C.16320 B3A.20040 E2A.35130 F1E.35110 A5.20180 B2B.35011 D2D.30280 S1F.35420 C1A.16520 D2D.30500 S1H.37840 D1D.22220 C1C.13230 J3D.28050 C1A.16280 B1B.24010 B1G.24241 G3H.50010 A2C.10050 S1H.37320 E1G.35150 C5.28160 S1D.35700 S1B.28300 C6.28220 S1E.50600 B1G.24261 A6.15180 H1E.35080 A5.18090 A5.13090 S1D.28280 B1G.24100 S1D.35240 D2E.30360 S1C.45110 S1B.28420 A5.23130 A2N.13100 A6.23170 A2A.10050 D2E.30160 S1H.37880 C5.28220 S1H.37560 S1D.35540 D2E.30220 S3B.35440 S1H.37900 C6.28150 S1H.50850 S3B.50280 D2E.30240 S3B.35160 A5.13050 H3E.35010 C5.28300 H1D.35130 J1B.24020 D2E.30290 S1D.28160 S1F.35520 B1B.28040 A6.23090 E2A.35200 E1G.35050 B1B.24020 A5.13130 B1B.22100 B2A.35081 S1D.35550 S1D.35110 S1H.37680 D2E.30190 B1J.27100 D2D.30120 A5.20150 B1B.22040 S1F.35140 S1C.45380 A2H8080 C1C.13370 S1H.37460 G3H.50020 S1D.35650 E2A.35170 C7.24200 A2T8100 A2C8070 J1G.24010 B1J.27160 S1D.35450 S1C.45450 S1D.28680 D1D.22210 A5.18080 A5.25100 A2B8080 C5.28150 S1H.50300 H1E.35060 A6.23110 E1A.35050 S3B.35280 D2D.30190 S1F.35700 B1B.28090 S1D.28320 C5.28170 S1E.50400 S1H.50125 B2A.35041 S1C.45800 S1C.45260 A5.23240 G1G.35030 S1D.28300 A5.15150 S1H.37620 S1H.50500 D1D.22300 B1B.24060 B1B.22010 B2A.35051 A5.25110 S1H.50115 D2E.30260 B1G.24301 S1D.28700 S3B.35400 H1E.35140 H1D.35010 F1E.35130 F1E.35150 C7.24160 B2B.35051 C6.28340 D2D.30290 S1E.50800 C1B.16350 S1D.28130 S1D.35580 F1E.35100 S1C.45100 S1H.37600 S1C.45620 S1F.35260 S3H.50650 F1E.35030 E1G.35140 C6.28160 D2D.30230 C7.37580 B1G.24120 H3E.35000 E1A.35020 A5.23170 A6.23140 A2E8070 B1J.27080 A5.23110 E2A.35190 B1B.22020 B1B.24030 S1D.35320 S1H.37480 A5.20160 A6.20240 S1D.35620 F1E.35060 D1E.22360 E1A.35080 B1J.27190 E2A.35180 S1B.28600 A5.20300 A2H8060 S1D.35160 C1B.13430 A6.23160 A5.20220 B1G.24101 E2A.35240 S1D.28580 C7.37540 A5.23070 S1C.45650 S1C.45520 A2G8060 S3H.50420 D2D.30110 S1B.28360 D2D.30140 D2D.30380 S1D.35190 S1B.28170 S1H.37860 C5.28200 E1G.35010 F1H.35010 A5.20090 S3B.50340 S3B.35320 A5.23120 S1B.28480 B1B.23020 S1F.35120 D2D.30320 S1H.37425 B1B.28070 A6.23080 B1J.27110 H1E.35180 S1D.35560 S3B.50480 A2H.10060 S1H.37820 B2A.35021 E1G.35170 A6.15160 S3H.50220 A5.20100 S1H.50110 S1C.45900 B1G.24281 A1R8010 D1E.22320 B2A.35031 S1D.28660 A6.20120 S1D.35220 K1H.50010 C7.37520 A5.15180 S1D.28450 A5.15110 S3B.50220 E1A.35100 S1H.50700 D2E.30380 H1E.35090 B1B.28030 S1C.45600 S3B.35180 B1B.28080 B2A.35071 B1J.27240 B2A.16010 S3B.50320 S1D.28100 S1F.35460 A6.20140 K1H.50040 S1F.35220 A2S8070 C5.28190 A2E8050 S1C.45440 S1H.37440 C7.37300 H1D.35120 S3B.50440 S1B.28160 B1G.24161 A6.23120 S1C.45480 S1B.28550 A2T.10100 S1H.37780 S1C.45950 H1D.35090 A6.20220 S1D.28200 S1B.28580 D2D.30270 C7.37380 D2D.30340 A2F8040 S3B.35300 C1C.16430 S1D.28120 A2F.10040 S3B.50400 C2A.16020 H1E.35030 S1B.28500 S1H.50105 B1B.24050 C6.28120 C2A.16060 H1E.35110 S1D.28240 A2B.10080 C6.28100 S3B.50800 A6.15060 A5.20200 D1D.22280 S1H.37580 C2A.16010 A5.25060 S1C.45580 S1B.28280 H1E.35190 S1E.50750 H1E.35100 B1G.24150 A2G.13060 A5.15120 B1G.24080 S1D.35180 S1D.28180 S3B.50420 C1C.16250 E1G.35130 A2A.10080 S1B.28380 S1B.28200 B1B.28050 E2A.35150 S1C.45300 A2L.10060 S1E.50950 A6.23150 C2A.13040 C6.28110 E1G.35040 A6.15130 S1D.28190 S1C.45360 H1D.35050 S1D.28360 B1G.24260 D1D.22190 S1B.28240 B2A.35011 D2E.30450 A2K.10060 E1G.35030 H1E.35160 B1G.24170 S1E.50500 S1F.35620 S1D.28520 E1G.35110 D2E.30270 B1B.22090 S1C.45320 S1D.35750 B1J.27300 C7.37400 A5.20190 H1E.35170 S1B.28620 A2D.10070 S1D.35140 S1F.35800 S1F.35480 A2S.13070 B1G.24090 E1G.35080 J3D.28100 D2D.30130 C7.37480 A2C.13100 C2A.13010 C5.28450 A5.20070

    Establishment Types

    Manufacture Medical Device