Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011530718

FEI Number

3011530718

Entity Name

OSTEONIC CO., LTD.

City/State/Country

Seoul, KR

Establishment Address

405Ho,505-2Ho,505-3Ho,508Ho,603Ho,706Ho,902Ho,1004Ho,1005Ho,1103Ho,12F, 38, Digital-ro 29-gil, Guro-gu, 102Ho, 103Ho,105Ho, 24, Digital-ro 27-gil, Guro-gu, 1012Ho, 1013Ho, 272, Digital-ro, Guro-gu, Seoul 08381, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

OSTEONIC Co., Ltd. (Owner Number: 10048673)

Owner / Operator Contact Address

1004Ho,1206Ho,38, Digital-ro 29-gil, Guro-gu, 102Ho, 103Ho, 24, Digital-ro 27-gil, Guro-gu, Seoul, KR-NOTA 08381, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Y1J.35020 Y7J.35010 Y1J.35010 C8P7020 Neuro Plating System ASA-2030-1110 ASA-3520-173N2 ASA-2530-2180 ASA-2530-3440 ASA-2530-3480 ASA-2030-1310 ASA-2030-2360 ASA-2530-2330 ASA-2530-3540 ASA-2530-2520 ASA-2030-2150 ASA-2030-2170 ASA-2030-2740 ASA-2530-2370 ASA-2030-2350 ASA-2030-2380 ASA-2530-2350 ASA-2030-1300 ASA-2530-3460 ASA-2530-2200 ASA-3520-172N ASA-2530-2380 ASA-2030-1130 Suture Wing ASA-2030-1120 ASA-3520-274N2 ASA-2030-1140 ASA-2530-3210 ASA-3520-173N ASA-2030-2200 ASA-2530-3550 ASA-2530-3490 ASA-2030-2180 ASA-2030-1820 ASA-2530-3220 ASA-3520-274N ASA-2530-2190 ASA-2530-3450 ASA-2530-3230 ASA-3520-172N2 ASA-2030-1720 ASA-2530-2360 ASA-2530-2170 ASA-2530-3430 ASA-2530-2150 ASA-2030-2370 ASA-2530-2340 ASA-2030-2190 ASA-2030-1830 ASA-2030-2840 ASA-2030-2340 ASA-2030-2160 ASA-2030-1730 ASA-2530-2160 ASA-2530-3240 ASA-2030-2330 Neuro Plating System Screw driver (various models) Neuro Plating System Screw driver body (various models) NDS-03 GDS-01 NDS-01 LDS-03 LDS-01 GDS-02 GDS-03 NDS-02 LDS-02 OPTIMUS CMF SYSTEM S1H.37300 S1F.35580 S1H.50250 A6.20260 S1D.35600 A5.15090 A2C.10070 A5.18100 C7.37500 S1F.35540 S3H.50500 B1B.24040 B1J.27090 A6.15090 A5.20260 A5.15060 B1J.27170 G3H.50030 B1B.22080 S1D.35200 S1E.50900 S1D.28420 A6.23200 B1B.22060 S1B.28460 H1E.35200 S3B.50460 B1G.24161 S1C.45480 H3E.35030 C7.24220 S1H.37780 C5.28110 H1D.35090 B1J.27260 S1D.28200 C7.24260 C7.37380 B1B.23010 A2F8040 C6.28180 S1C.45550 S1D.28120 S3B.50400 E2A.35160 H1E.35030 S1B.28180 D1D.22200 C6.28190 S1B.28500 B1B.24050 B1J.27120 C6.28120 A5.13100 D1E.22380 S1H.37540 S1F.35280 A6.23190 D1D.22180 S3B.50650 S1H.37750 C7.37360 S1B.28340 B1G.24181 S1H.50800 S1B.28150 C7.37320 A5.15190 A5.18110 S1H.37475 S1B.28130 A2K8060 S1H.37350 S1H.37850 C6.28360 S1H.50400 A5.20110 C1A.16520 A2J.10060 B1J.27220 S1F.35450 B1B.22070 C2A.13050 C5.28120 S1D.35170 S1H.37325 C5.28180 A6.20180 F1E.35010 C6.28240 S3H.50240 S1F.35200 C7.37560 C1B.16470 D1D.22230 S1H.50600 D2E.30320 A5.15160 S1F.35400 A6.20170 S1D.28620 D2E.30230 A5.23110 E2A.35190 S1D.35320 C6.28320 A6.20240 S1D.35620 S1D.35750 B1J.27300 D2D.30200 S1B.28620 E1A.35080 B1G.24201 H1D.35110 E2A.35180 S1H.37660 D2D.30210 S1H.37550 C7.37340 J3D.28100 S1B.28520 B1B.28020 B1G.24101 C7.37480 E2A.35240 S1D.28580 H1E.35110 S1C.45240 A2B.10080 A5.13080 A6.15060 A5.20200 S1H.37580 D2E.30200 D2D.30250 S1D.35360 D1D.22130 A2U8090 C7.37600 S1H.50130 C2A.16050 S1D.35440 D1E.22280 D1D.22100 S3H.50280 A5.23260 S3B.50550 A2A.10080 S3B.35380 S1B.28200 S1C.45650 B1G.24200 A2G8060 S1B.28700 A6.15100 S1B.28360 D2D.30380 H1E.35150 S3B.35220 S1H.50650 B1G.24180 H1E.35040 B1G.24280 C1A.13490 A5.23060 B1B.24090 A2A.10040 S1F.35180 S3H.50320 S3B.35340 S1F.35360 S1H.37425 S1C.45220 B1B.28070 A2L8060 S1C.45110 F1E.35020 A5.23130 A5.20160 B1G.24121 A6.23170 C7.24240 D2E.30160 S1D.35190 D2E.30220 S1H.37900 D2E.30240 E1G.35010 C5.28300 A5.20090 S1F.35520 S3B.35320 S1H.37575 E1G.35050 S1B.28480 B1B.22100 S1F.35120 S1D.35110 C1A.13270 D2E.30190 S3B.50220 S1E.50800 D2E.30380 H1E.35090 S1D.28130 S3B.35160 H3E.35010 B1B.28030 S1C.45600 A5.18080 A5.25100 B2A.35071 B1J.27240 A2B8080 C5.28150 H1E.35060 S1C.45380 S3B.35280 D2D.30190 C1C.13370 A2S8070 C5.28190 S1F.35700 B1B.28090 S1H.37440 C7.37300 S1B.28680 D2E.30400 C2A.16060 E2A.35230 S1D.28240 C6.28100 S1H.37875 S3B.50800 D1D.22280 A5.18120 A5.25060 H1D.35070 S1C.45580 A5.15170 S1H.37700 S1E.50750 D1D.22250 B1G.24150 G1H.50020 A2D8110 A5.15120 C5.28240 A2G.10060 B1G.24190 C1C.16250 A5.20240 A2M.13060 A6.20150 S1F.35320 C5.28140 S1E.50850 S3B.35200 C5.28400 S1B.28640 A6.15200 S1D.28440 H3E.35060 S1F.35300 C1D.16340 J3D.28020 S1D.35420 S1B.28260 S1F.35160 D2D.30450 A5.15080 D1E.22220 A5.15200 S1H.37800 A6.20100 S1H.50120 D2D.30150 S1F.35380 F1E.35150 B2B.35051 C6.28340 A2N.13060 C1B.16350 S1F.35100 S1D.35580 A2D.10090 S1C.45100 S1D.28160 S1C.45620 S1F.35260 A6.23090 B1B.24020 S1D.35550 B1J.27100 D2D.30120 D2D.30230 A2H8080 H3E.35000 S1H.37460 B1J.27140 A5.23170 A2E8070 C1A.13380 B1G.24160 S3B.50500 A5.13120 S3B.35460 A5.23240 G1G.35030 S3H.50440 B1G.24240 A6.23150 C2A.13040 B1G.24221 C6.28110 E1G.35040 A6.15130 H1D.35050 B1G.24301 D1D.22190 S1B.28240 D2D.30100 S3B.50700 B2A.35011 D2E.30450 S3B.35420 D1D.22140 S1E.50500 B3A.20030 B1B.22020 B1B.24030 C1D.16390 S1H.37480 B1J.27200 B2B.35021 C7.37400 C5.28220 B1B.22030 S1H.37560 S3B.50280 S1B.28600 A5.13050 A6.15110 C5.28130 B1B.28040 S3B.50360 E2A.35200 A5.13130 A2C.13100 S1E.50105 A5.20070 C7.37540 D2D.30220 SIGNEX A5.20080 S1H.50125 B2A.35041 S1C.45800 S1C.45260 A5.15150 S1H.37620 A2A8060 S1F.35600 S1E.50650 S1B.28450 A6.20160 S1C.45400 B2A.35051 A5.25110 S1H.37720 J3D.28040 B2B.35081 A6.20080 H1E.35010 A5.23300 E1G.35180 B1B.27020 F1E.35130 A2M.13100 S1D.35540 A5.15110 E2A.35170 C7.24200 E1A.35100 A2T8100 A2C8070 J1G.24010 S1C.45450 D2E.30290 S3B.50600 B2A.16010 F1E.35080 S1F.35460 S1H.50300 C1B.13320 A2U.13090 A6.23110 A5.18070 D2D.30400 E1G.35120 A2J8080 G3H.50020 C5.28170 S1E.50400 H1D.35120 S3B.50440 S1D.28220 A6.23120 D2E.30250 S1B.28550 A2T.10100 A5.15130 A5.18060 C7.37460 S1C.45280 D1E.22340 S3H.50460 D1E.22400 D1E.22260 E2A.35220 S3B.35300 A5.15100 A2J.13060 S1B.28540 B1G.24300 C1C.16320 B3A.20040 E2A.35130 A5.20180 B2B.35011 S1H.50105 S3B.50200 S1H.50550 S1F.35620 S1D.28520 S1H.37825 A6.20300 A5.25140 E1G.35110 D2E.30270 B1B.22090 S1C.45320 F1E.35060 D1E.22360 B1J.27190 D2D.30170 A5.20300 A2H8060 S1H.37360 S1F.35480 A2S.13070 S1D.35160 C1B.13430 A6.23160 A5.20220 C2A.13010 C5.28450 C5.28320 S1D.35260 S1D.28480 S3H.50380 S1B.28660 D2D.30240 A2A8120 E1A.35040 J1B.24010 A6.20070 D1D.22150 F1E.35100 S1H.37600 A6.15140 D1E.22300 S3H.50650 A5.23100 E1G.35140 H3E.35020 F1E.35050 C6.28160 C7.37580 D2D.30260 B1G.24120 S1D.28150 E1A.35020 H1E.35050 A5.23280 D2D.30180 A5.20120 H1E.35070 S1H.37375 A2S.10070 A6.23060 S1D.28540 B1B.22050 S1D.35340 S1C.45340 B1J.27130 S1F.35670 F1E.35120 S1H.37420 A2C8060 S1C.45640 B1B.27010 S3H.50300 C6.28440 C2A.16030 H1E.35120 C6.28140 S1D.28600 S1D.35480 F1E.35090 C5.28280 S1D.35300 S1H.50700 S1D.35150 B1J.27160 S1D.35450 S3B.50240 S1D.28680 J1G.24030 E2A.35140 S1D.35400 D2E.30180 E2A.35250 C2A.13020 S1H.50135 F1E.35140 E1A.35050 A5.25090 S1C.45700 S1C.45200 C6.28380 S1D.28560 H1D.35140 C7.24140 S1B.28160 S1H.50140 C7.24160 S3B.35440 D2D.30290 C6.28150 S1H.50850 H1D.35130 J1B.24020 A5.23140 S3B.35180 B1B.28080 S3B.50320 S1D.28100 F1E.35030 S1H.37680 A6.20140 A5.20150 K1H.50040 S1F.35220 A2E8050 S1C.45440 S3H.50340 A6.23140 S1D.35650 B1J.27080 G1H.50010 S3H.50700 S3H.50420 A5.23090 H1E.35130 S1H.37525 B2B.35071 C6.28130 D1D.22170 S1F.35650 D1D.22300 S1D.35120 B1B.24060 B1B.22010 S1H.50115 D2E.30260 S1C.45420 A5.13110 S1D.28700 B1B.24070 C6.28420 S3B.35400 H1E.35140 A6.15150 A6.20280 S1C.45460 A5.13060 D1D.22110 E1G.35020 A2G8100 A5.20140 S1F.35750 S1D.28550 S3H.50200 B1B.24080 D2E.30500 A5.20060 A6.20200 S1H.37450 S1B.28560 S1F.35440 S3H.50260 A6.15070 S3H.50600 H1D.35030 S1H.37500 S1B.28220 D2E.30210 C6.28400 H3E.35050 S1H.37725 A5.15070 S1B.28440 A6.23080 H1E.35180 S1B.28140 S1D.35560 A6.23100 A2H.10060 S1D.28140 E1G.35170 A5.20100 S1H.37675 S1C.45900 S1H.37380 B1G.24281 A1R8010 S1E.50100 S1H.37400 B2A.35031 S1H.37640 A6.20120 S1C.45660 K1H.50010 A5.15140 S1D.35520 A5.15180 S3B.35120 D2E.30360 A5.23070 S1B.28420 S1C.45520 A2N.13100 D2D.30110 A2A.10050 D2D.30140 S1H.37880 S1B.28170 E1A.35010 S1H.37860 C5.28200 S3H.50480 B2B.35061 F1H.35010 S3B.35260 S3B.50340 S1H.50900 A5.23120 B1G.24130 B1B.23020 S1B.28110 B2A.35081 D2D.30320 B1B.22040 S1F.35140 S1D.28180 D2D.30500 C7.37440 B1B.28050 D1D.22220 S1C.45300 J3D.28050 B1B.24010 S1E.50950 B1G.24241 E1G.35150 A2H.13060 S1D.35700 A2T.13100 S1B.28300 S1D.28640 B1G.24260 B1G.24261 D2D.30360 H1E.35080 S1D.28380 S1H.50100 A5.13090 C1C.13300 B1G.24100 S1D.28340 A5.25080 E1G.35090 B1G.24141 C7.24180 S1C.45540 B2A.35021 B1J.27150 E1A.35030 C6.28260 A5.20190 H1E.35170 S1B.28320 C1A.16400 A2D.10070 B1B.28100 S1D.35140 S1F.35800 B1G.24090 E1G.35080 S1D.35460 C2A.13030 D2D.30130 D2E.30170 D2E.30340 H1D.35100 E1G.35160 S3H.50400 A5.25120 E1G.35130 A6.15120 S1B.28380 E2A.35150 S1D.28300 A2L.10060 S1H.50500 C6.28300 S1H.37320 S3H.50800 C5.28160 S1D.28190 S1C.45360 C6.28220 S1D.28360 S1E.50600 A6.15180 A5.23150 A5.18090 H1D.35010 H3E.35070 A2K.10060 E1G.35030 J3D.28010 H1E.35160 B1G.24170 H1D.35040 A5.23220 A6.20130 S1H.37520 S1C.45950 K1H.50030 S1B.28190 S1D.35100 D2D.30160 S1E.50110 S1F.35560 E1A.35120 A5.23160 A6.23130 S1D.35380 S1H.50950 A6.23070 A5.23080 C2A.13060 S1E.50700 F1E.35110 S1H.50750 C5.28340 D2D.30280 S1F.35420 D1D.22240 A6.15080 A2U.10090 B1G.24140 E1G.35070 S1F.35340 C6.28450 B1B.28010 S1C.45560 S1F.35240 S3B.50300 D1D.22260 S1D.28460 B1B.24100 C7.24280 S1F.35500 S1D.28400 D2E.30300 A5.13070 B1J.27280 A6.15170 S1C.45850 S3B.35360 S3B.50380 S1D.35800 E1A.35090 B2B.35031 S1D.28170 C6.28170 B1J.27180 A5.23180 S3H.50550 C2A.16040 G3H.50040 S1H.37340 D1D.22210 E1G.35060 S3B.50260 S3H.50220 S3B.35240 S1H.50110 S1C.45105 A2A.13050 D1D.22120 D1E.22320 A5.25130 S1D.28660 E2A.35260 S1D.35220 S1D.28320 J1G.24020 D1E.22240 S1H.37740 H1D.35080 B2A.35061 S1H.37840 E1A.35060 C1C.13230 A6.20090 C1A.16280 C5.28360 G3H.50010 A2C.10050 B1G.24110 A6.20220 S1B.28580 A2A8040 D2D.30270 E1A.35070 D2D.30340 C5.28260 C1C.16430 A5.20280 A2F.10040 J3D.28060 C2A.16020 S1H.37760 S1D.28280 S1D.35240 D1D.22270 S1D.35130 E2A.35210 S3B.35140 H1D.35020 S1D.28260 A5.13140 A5.20170 J3D.28070 E1G.35100 B2B.35041 J3D.28030 C5.28380 J3D.28090 C7.37420 S1H.50350 H3E.35040 A6.15190 B1B.28060 A5.25070 S1B.28400 C6.28280 S1H.50450 F1E.35160 S1H.37650 D2D.30300 S1B.28120 A6.20190 C5.28100 A6.20110 S1H.37625 A6.20060 S1C.45680 S3H.50750 C2A.16010 H1D.35060 B1G.24220 S1D.28500 S1F.35550 S3H.50360 S1B.28280 A5.23190 H1E.35190 H1E.35100 A6.23180 A2G.13060 D1D.22160 S1D.35500 B1G.24080 S1D.35180 D1D.22290 S3B.50420 J3D.28080 A2J8060 B1J.27110 S1D.28110 S3B.50480 S1D.35280 S1H.37820 F1E.35040 K1H.50020 A6.15160 S1B.28100 H1E.35020 S1C.45750 A5.23200 E1A.35110 S1H.37775 A5.20130 S3B.50750 C6.28200 S1E.50450 D2E.30280 F1E.35070 S1E.50550 C7.37520 S1D.28450 S1C.45500 D9Q1020 Z1Z3010 Z1Z2010 Z1A.50010 Tray (various models) PSK-001 TPF-002 TSF-001 TPO-003 PHL-001 TPN-002 TPM-003 TPN-007 TCN-001 TSM-003 TSN-001 TPO-002 MFK-001 TSM-001 TPM-002 TPF-001 TPN-001 TSM-004 TPN-003 Z1C3010 B1Q101 Z1B3010 TCP-001 Z1C.50010 Z1B.50010 Z1Y3010 Z1Z1010 Z1Z1030 Z1M3020 Z1A1010 Z1Z1040 Z1C2010 Z1Y1120 Z1F3010 Z1M3010 Z1Y1410 Z1C1010 TSM-002 Z1Y1110 Z1Y1210 Z1M1010 Z1Z1050 GIN-006 Z1Y1220 Z1Z1020 TPN-005 TCM-002 TSO-001 TPM-001 PLL-001 Z1B1010 Z1B2010 Z1A3010 Z1C.20010 TCP-002 TCM-001 Z1B2010-ACE TPO-001 TPM-004 TIN-006 TPF-003 Z1B1010-ACE Z1M.35010 C9Q1010 Z1M.50010 Z1Y1320 Z1M.50020 Y1L3020 Z1Y2010 Y1L3010 A9101 Z1B3010-AC Z1Y1310 Z1F2010 Z1Z.50010 Z1B.50010-AC Z1F.50010 Z1A2010 Z1Y.50010 Z1F1010 ASTER D8P3120 D8P3090 Y1G.35020 Optimus CMF System - Depth gauge (various models) IOC-110 IOC-100 Y1G.24020 Y1G.35040 Y1G.73020 Y1G.50030 Y1G.50040 Y1G.35060 Y1G.35050 D8P3150 PUNCH, SURGICAL(various models) POWER SCREWDRIVER IOC-141 PLD-4521-1130 110047672 PHA-4816-2200 PHA-4816-3550 PSA-1808-274N 110047699 PHA-4816-2380 PHA-4816-1310 PLA-5521-1910 PLD-5521-1130 110047701 110047698 110047696 110047697 PHA-4816-2520 PSA-1808-172N PHA-4816-2180 PHD-4521-1030 PHL-4521-1910 Fix2Lock(PEEK Self Punching) PHD-4521-1130 PHA-4816-3490 PHA-4816-3240 PHL-5521-1910 110047665 110047670 110047700 110047668 110047669 110047695 PHD-5521-1030 110047667 PHD-5521-1130 110047671 PLD-4521-1030 PSA-1808-274N2 PLD-5521-1030 110047666 PLA-4521-1910 PSA-1808-172N2 Y1A.25020 C8P.31200 Y1A.22010 Optimus CMF System - Trocar set (various models) Optimus CMF System - Surgical drill bit-non power (various models) Optimus CMF System - Drill guide (various models) IOC-093 FDB-06 IOC-161 ODB-04 ODB-01 FDB-17 ODB-09 ODB-07 FDB-14 FDB-10 ODB-12 ODB-06 FDB-13 ODB-14 FDB-20 110045297 FDB-16 IOC-160 ODB-03 MDB-01 IOC-094 FDB-07 IOC-095 FDB-08 ODB-10 BIS-2110-DR FDB-09 ODB-11 FDB-01 MDB-02 ODB-08 FDB-15 ODB-05 FDB-12 ODB-15 A8.2302 Y1A.35020 Y7A.32010 BIS-2610-DR IOC-151 ODB-02 Y1A.38020 FDB-02 MDB-03 Y1A.32010 B1P.3101 Y7A.30010 B1P.3201 IOC-092 FDB-03 MDB-04 Y1A.43010 FDB-05 Y1A.30020 MDB-07 IOC-150 Y1A.43020 NDB-02 Y1A.37010 MDB-05 MDB-06 110045296 FDB-19 NDB-01 FDB-11 ODB-13 FDB-04 MDB-08 IOC-091 FDB-18 MDB-09 Y1A.45020 375DRILL Y1A.24020 Y1A.28010 Y1A.35010 Y1A.30010 650DRILL A8.2301 Y1A.21010 Y7A.43010 A8.2304 475DRILL Y1A.28020 C8P.31230 D8P.31170 550DRILL Y1A.18010 D8P.31210 Y1A.22020 Genie RCR Instruments BHA-5320-AWL BMA-4518-AWL 110045261 110045278 475AD BMA-5519-AWL BHA-4820-AWL BLA-4750-PUNCH 110045276 110045274 475AWL DDS-06 Optimus CMF System - Screw driver (various models) Optimus CMF System - Screw driver body (various models) IOC-010 FDS-05 IDS-01 IOC-012 ACL-0329-DRIVER-1 FDS-02 ODS-02 MDS-03 IDS-03 110045321 FDS-04 FDS-01 110045320 FDS-03 IOC-017 Y1B.35010 IOC-018 MDS-01 Y7D4010 IOC-011 C8P.22050R C8P.22030 Y1B.35020 Y7D.35010 A8104 Y7D.25010 C8P.22040 Y7B.35010 IDS-02 IOC-013 Y7B.25010 Y1B.28010 C8P.22060R MDS-02 D8P.22010 ODS-04 Y1D.50010 ODS-01 ODS-03 C8P.22060W PIS-0430-DRIVER C8P.26060 DDS-07 D8P.22020 A8103 C8P.22040R A8102 Y1B.50020 Y1B.50030 Y1B.28011 B1P.2301 C8P.22050W C8P.26050 C8P.26040 Genie RCR Instruments BHA-5320-TAP BMA-5519-TAP 110047702 PLA-4521-TAP BMA-5519-TAP-1 375BKT 375TAP 110045277 110046508 BHA-4816-TAP Y1M.50020 BHA-4820-TAP BMA-4518-TAP 110045273 Y1M.50010 110045275 475TAP Y7Z0020 Y7Z0010 C8P0010 475BCBC 375BCP 550BCBC 475BCPSP 650BCPSP 550BCPSP C5.35300 S1B.50280 G3F.35150 C6.35150 G3E.35150 L4B.50110 B2A.35022 B2A.35021 C5.35280 C7.30480 S1B.35450 S3F.45300 S3F.45540 G3E.50120 S3F.45380 S1B.50400 S1B.35220 G3E.35110 C6.35180 C6.35480 L4C.50120 C6.35620 C7.37380 G3E.35140 S1B.35260 G1F.35100 S1B.50260 L4B.50080 G3F.35130 B2A.35051 S1B.50360 C5.35120 G1C.35070 B2B.35051 C7.30320 S1B.35540 K1E.50050 C6.35320 S1B.50550 S1B.35440 K1E.50100 S3F.45260 L4A.35011 C5.35500 G3F.35180 G3F.35100 G1F.35160 J2G.35031 L4C.50150 C6.35160 L3A.35051 G3E.35030 C7.30180 S1B.50420 G1F.35150 C5.35190 C7.30300 L2A.35140 C6.35100 K1E.50140 C7.30280 S1B.35420 L2A.35130 G3F.35020 C7.30360 G3F.50140 G1C.35050 S3F.45320 G3F.35110 L4A.35021 L4A.35141 S1B.50500 G1C.35100 S1B.50850 C5.35600 C7.37580 C5.35320 C6.35380 C6.35540 C7.30140 K1E.50120 S1B.35800 J2G.35012 G1F.35050 L4A.35151 G3E.50040 C7.37520 S1B.35150 G3E.35040 A1A6120 S1B.50480 C6.35120 C7.30260 S1B.35400 B2B.35041 G3F.50010 G3E.50160 A1J6060 J2G.35071 L4B.50140 B1D.22020 L4A.35071 A3A.13040 G3F.50020 C7.37560 G3F.50030 L3A.35041 G3F.35170 L4B.50160 C6.35500 C5.35550 K1E.50040 B2A.35011 L4A.35111 G1C.35020 C6.35400 G3F.35080 G1F.35140 S1B.35520 S1B.35360 L3A.35061 C6.35440 S3F.45340 G3F.50090 C6.35460 A3M.13100 G1F.35090 J2G.35081 B2A.35031 G3E.50080 G3E.50090 C6.35340 S3F.45220 S3F.45460 B1D.29010 C5.35150 G3E.50060 L4C.50170 L4C.50180 K1E.50060 S1B.35170 A1C6070 S1B.35180 L4C.50130 G3E.50030 S3F.45580 G1F.35110 C7.37400 B1D.22030 G1F.35080 G3E.35060 L4A.35091 L3A.35011 A1R6010 G3F.35060 L4A.35031 S1B.35300 C6.35450 S3F.45240 C7.30220 C6.35260 C7.24140 B1D.29020 C6.35130 G1F.35030 L4B.50150 L4C.50010 G3E.35130 C7.30160 L4C.50030 C7.30340 G3F.50160 B2B.35011 S1B.50700 L4A.35081 C5.35340 J2G.35021 C7.37540 G3F.35050 L4B.50040 C6.35280 S1B.35550 K1E.50070 S1B.35320 B1D.22040 C6.35240 L4A.35131 S1B.50800 S1B.35240 S1B.35650 S1B.50450 L4B.50090 C7.37480 B2A.35012 G1F.35060 G1C.35030 L4B.50120 C7.37600 S3F.45600 G3F.50080 C6.35220 L3A.35031 K1E.50020 K2E.50030 C6.35580 G3F.50060 L4B.50010 G3F.50110 C7.37500 C6.35420 L4C.50110 C5.35110 B2B.35071 G1F.35020 S1B.35110 A1H6060 S1B.50460 G1C.35060 G3F.50100 C6.35200 C7.30460 C6.35600 C7.24260 C6.35360 A1L6060 L4C.50100 C6.35110 S1B.50750 A1E6070 B2A.35081 G1C.35010 C5.35380 C5.35200 G1F.35120 G3E.35100 K1E.50010 L4B.50050 G3E.35070 S1B.35480 C7.24180 S1B.35380 B2B.35021 L4C.50020 S1B.35560 C7.37340 S3F.45420 C5.35180 C7.24280 A1G6100 L4C.50090 G3E.35090 L4A.35041 C5.35140 S1B.50440 L3A.35121 S1B.50380 S1B.35580 K1E.50090 B2B.35061 C7.30420 S3F.45440 C7.24220 L3A.35101 L2A.35120 C7.30500 C6.35560 S1B.35600 C6.35550 L2A.35110 C5.35220 J2G.35022 K2E.50010 S1B.50340 L4C.50080 S1B.35700 A3N.13100 C7.24240 S3F.45360 L3A.35081 G3E.50110 C7.24160 S1B.35750 C7.30380 J2G.35011 C7.37300 G3F.50130 L4A.35171 B2B.35031 B1D.22010 S1B.50300 G3E.50070 G3E.35050 S1B.35340 L2A.35170 J2G.35051 C5.35130 C6.35170 S1B.35130 C7.30200 L4B.50130 L4C.50140 G1F.35010 L4C.50160 C7.30400 L4C.50070 S1B.50240 G1C.35040 B1D.25030 G3F.50120 J2G.35041 G3E.35010 S1B.50200 S1B.35140 G3E.50100 C6.35300 L4C.50050 L4C.50040 L4A.35121 B1D.25020 L4B.50060 G3E.35080 S1B.50220 S1B.50900 L4A.35051 A1J6080 S1B.35280 C7.37460 A3C.13100 S1B.35500 S3F.45280 G3F.35070 S1B.35190 S3F.45200 L4B.50030 A3A.13080 S1B.50320 L4A.35181 G1C.35080 S3F.45520 S1B.35200 C6.35140 G3F.35160 G3F.35120 G3F.50070 S3F.45400 L3A.35091 S1B.35160 G3E.50140 G3E.50150 G3E.35160 C5.35100 L4A.35161 S1B.50650 G1F.35040 L4C.50060 A1G6060 K2E.50020 L2A.35150 G1F.35070 C7.37360 K1E.50110 C5.35160 G3F.50050 L2A.35160 G3E.50130 G3F.50150 K1E.50030 B2A.35071 G3F.50180 J2G.35061 S3F.45480 B2B.35081 A1K6060 B2A.35041 C7.30240 L3A.35021 C6.35190 C6.35520 C7.37420 S1B.35120 C5.35260 L4A.35061 G3F.50040 G3F.35090 S1B.35620 G3F.50170 C7.24200 C7.37320 L4B.50100 S3F.45560 C5.35360 G3E.35020 G3E.50050 G3F.35030 L4A.35191 G1F.35130 L3A.35111 K1E.50130 S1B.35100 C5.35240 B1D.25040 C7.30440 A1A6040 S1B.50160 S1B.50600 L4A.35101 L4B.50070 S1B.50140 C5.35170 B1D.25010 S1B.35460 A1H6080 G3E.50010 G3E.50020 S1B.50180 S3F.45500 G1C.35090 G3F.35040 L4B.50020 G3F.35140 L3A.35071 G3F.35010 C5.35450 C7.37440 K1E.50080 B2A.35061 G3E.35120 C5.35400 Optimus CMF System - Bender (various models) Optimus CMF System - Bending guide (various models) Neuro Plating System-Bender (various models) IOC-080 IOC-127 IOC-125 IOC-121 IOC-124 IOC-123 IOC-120 IOC-070 IOC-021 IOC-180 IOC-126 IOC-020 IOC-171 IOC-122 IOC-170 Neuro Plating System Fix2Lock (PEEK Self Punching) PHL-4521-1120 PLA-4521-1030 PLA-5521-1120 PHL-5521-1030 PHL-5521-1120 PLA-5521-1110 PLA-5521-1140 PLA-4521-1120 PHL-5521-1140 PLA-4521-1110 PHL-5521-1130 PHL-4521-1140 PHL-4521-1130 PLA-4521-1130 110045254 PHL-4521-1030 PLA-4521-1140 110045256 PHL-4521-1110 PLA-5521-1030 PHL-5521-1110 110045255 PLA-5521-1130 110045257 Suture Wing ASA-2025-1110 ASA-2025-1130 ASA-2025-1140 ASA-2025-2200 ASA-2025-2190 ASA-2025-2170 ASA-2025-2150 ASA-2025-2160 ASA-2025-1120 ASA-2025-2180 Neuro Plating System POWER SYSTEM Y2C.15020 T4A8060 T4A.12010 T4A7050 T4A7010F T4A.10070 T4B.12010 T4A.10030 T4A8070 T4A.12030 T4A8020F T4A8010 T4A.12050 T4A7030F T4A.10010 T4A8020 T4A8030F T4B7010 T4A8030 T4B.10010 T4A.10020 T4A7010 T4A.10060 T4A7040 T4A.10010F T4A8010F T4A.12030F T4A.12040 T4A.12010F T4A7020F T4A.10040 T4A.10030F T4A8040 T4A.10020F T4A7030 T4A.10050 T4A.12020 T4A.12020F T4A7020 T4A8050 PEEK ACL screw NEO ADVANCE 110045314 110045318 PIS0830-PK PIS0930-PK 110045317 PIS0730-PK PIS0725-PK PIS0825-PK PIS1025-PK 110045313 110045319 PIS1030-PK 110045312 110045316 PIS0925-PK 110045315 Fix2Lock(Biocomposite medial, Biocomposite lateral, Biocombi Self Punching) BPL-4750-1910 BIN-2612-2740 BPH-4521-1910 BHD-5021-1030 110047693 110047673 BIS-2610-1820 110047692 BIS-2110-2840 110047689 BSA-2110-274N BSA-2110-274N2 BHA-4816-2380 110047663 BHA-4816-3240 BIN-2612-1130 110047690 BHA-4816-2180 BPH-5021-1910 BHA-4816-2520 BHA-4816-3490 BIN-2612-2840 BIN-2612-1820 BSA-2110-172N 110047675 BHA-4816-3550 BIN-2612-2180 BIS-2610-2840 110047688 BIS-2110-1820 BLA-4750-1910 BIN-2612-2200 BHD-4521-1030 BLA-4722-1910 BIN-2612-1720 BHA-4816-1310 BPD-4750-1030 BHA-4816-2200 110047674 110047694 BSA-2110-172N2 110047691 ORTHO MI SYSTEM Y1F.50010 C8P4020 Y7Z0040 Y1C.28010 B1P702 A8202 Genie Labral Instruments 375PKT Y1F.35010 Y1A.25010 B1P703 Y7Z0060 Y1Z.25010 C8P2070 Y1F.35040 A8902 Y1Z8030 Y1F.50020 Y1F.35030 B1P203 C8P4030 Y1C.35020 Y1Z.35030 Y1F.45020 Y1Z.28020 Y1Z.11010 110045295 BIS-04225-DG Y1D.50020 C8P1010 Y1F.35020 Y7Z0070 C8P2080 Y7F.50020 Y1F.28040 A8901 C8P2010 Y7Z.45010 B1P204 Y7F.35010 Y1Z.14010 Y7Z0050 Y1Z.16010 D8P4110 Y1D.35010 Y7F.50010 Y7Z0030 C8P2030 C8P2090 A8201 Y1F.28030 D8P2010 Y7F.35020 B1P701 Y7Z.40010 D8P4080 Y1F.45030 Y1F.28010 Y7D.15010 Y1F.35070 550PPSP 375PP 475PPSP 650PPSP Y7Z.10010 Y7Z.25010 Y7Z.10020 Y7Z.15020 Y7Z.20010 Y7Z.15010 Y7Z.20020 B2P304 Y1E.35010 B2P306 Y1Z.50010 Y1E.50020 B1P304 Y1Z.28010 Y1E.35020 B1P301 B2P301 Y1E.50010 Instrument B1P704 B1P305 B1P306 Y1Z.43010 Y1Z.22010 B1P302 B1P105 B2P303 B2P302 C8P4040 B2P305 B1P303 Optimus Neuro System - Surgical cutter (various models) Optimus CMF System - Surgical cutter (various models) IOC-050 IOC-060 IOC-040 IOC-041 IOC-051

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HXP	Instrument, Bending Or Contouring	Orthopedic	Class 1	888.4540	2025-06-09
GXR	Cover, Burr Hole	Neurology	Class 2	882.5250	2015-02-10
HBW	Fastener, Plate, Cranioplasty	Neurology	Class 2	882.5360	2015-02-10
GWO	Plate, Cranioplasty, Preformed, Alterable	Neurology	Class 2	882.5320	2015-02-10
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2024-05-02
GXL	Screwdriver, Skullplate	Neurology	Class 1	882.4900	2015-03-03
DZL	Screw, Fixation, Intraosseous	Dental	Class 2	872.4880	2023-10-31
JEY	Plate, Bone	Dental	Class 2	872.4760	2023-10-31
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2024-06-25
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2024-06-25
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2015-03-03
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2026-03-15
HTJ	Gauge, Depth	Orthopedic	Class 1	888.4300	2015-03-03
LRY	Punch, Surgical	General, Plastic Surgery	Class 1	878.4800	2022-08-04
KIJ	Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2018-05-02
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2023-10-31
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2015-03-03
HWJ	Awl	Orthopedic	Class 1	888.4540	2021-07-19
HXX	Screwdriver	Orthopedic	Class 1	888.4540	2015-03-03
HWX	Tap, Bone	Orthopedic	Class 1	888.4540	2021-07-19
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2025-06-09
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2024-12-09
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2024-12-09
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2025-06-09
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2025-06-09
HXW	Bender	Orthopedic	Class 1	888.4540	2015-03-03
HBW	Fastener, Plate, Cranioplasty	Neurology	Class 2	882.5360	2022-02-15
GXR	Cover, Burr Hole	Neurology	Class 2	882.5250	2022-02-15
GWO	Plate, Cranioplasty, Preformed, Alterable	Neurology	Class 2	882.5320	2022-02-15
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2021-06-28
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2021-06-28
GXR	Cover, Burr Hole	Neurology	Class 2	882.5250	2019-01-08
GWO	Plate, Cranioplasty, Preformed, Alterable	Neurology	Class 2	882.5320	2019-01-08
HBW	Fastener, Plate, Cranioplasty	Neurology	Class 2	882.5360	2019-01-08
DYJ	Retainer, Screw Expansion, Orthodontic	Dental	Class 1	872.5410	2022-02-15
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2020-12-16
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2023-10-31
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2023-10-31
OAT	Implant, Endosseous, Orthodontic	Dental	Class 2	872.3640	2021-11-29
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2021-07-19
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2024-12-09
FZO	Chisel, Surgical, Manual	General, Plastic Surgery	Class 1	878.4800	2025-06-09
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2022-08-04
FZT	Cutter, Surgical	General, Plastic Surgery	Class 1	878.4800	2015-03-03

Official Correspondent

Dong Won Lee

US Agent Details

David Hyun Jun Paek Email: dpaek.rennes@gmail.com Phone: (818) 9030660

Related Public Records

Same Entity

OSTEONIC Co., Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K193295	Parcus Medical, LLC	Parcus Knotless PEEK and PEEK CF Push-In Suture Anchor	2020-01-23
K193606	Conmed Corporation	Y-Knot OneStep Anchor	2020-01-22
K984200	R. Thomas Grotz, M.D., Inc.	STABILIZER SOFT TISSUE ANCHOR, 5 AND 8MM; ANCHOR INSERTER, 5 AND 8MM; STABILIZER DRILL, 5 AND 8MM, NONSTERILE; STABILIZE	1999-01-21
K171060	Riverpoint Medical	OrthoButton AL	2017-06-02
K231867	Paragon 28, Inc.	Grappler Suture Anchor System	2023-08-21

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0043-2007	Bioplate Inc	2	Bioplate Resorbable Bone Fixation Tack, Catalog Number: 89-0120, Item Number: SG#-45
Z-0014-2014	Synthes USA HQ, Inc.	2	Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, osteotomies, nonunions, and fusions of large bones in the foot and ankle.
Z-0026-2013	Orthohelix Surgical Designs Inc	2	OrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Z-0026-2016	Ortho Solutions Inc 330 Franklin Tnpk	2	Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, Unit 5 West Station Business Park, Spital Road, Maldon, Essex CM96FF Rx Only a) Sterile b) Non-Sterile Orthopaedic Bone Screw
Z-0027-2013	Orthohelix Surgical Designs Inc	2	OrthoHelix Part #HCS-056-32 3.8MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.

Similar Registrations

Registration Number	Establishment Name	Location
2647346	MEDTRONIC PUERTO RICO OPERATIONS CO., HUMACAO	HUMACAO, PR, US
3010049501	JATEX, INC.	Nappanee, IN, US
3013846070	GREENS SURGICALS PRIVATE LIMITED	Vadodara Gujarat, IN
3006846753	Bradshaw Medical Inc.	Kenosha, WI, US
3010531060	OSSEUS FUSION SYSTEMS LLC	Dallas, TX, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011530718. Last updated year: 2026. Please use registration number 3011530718 when referencing this establishment in official correspondence.