Osteonic Co L T D

FDA Filings

This page includes the latest FDA filings for Osteonic Co L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

KOREA REP OF

KOREA EXCHANGE (KOSDAQ)

226400

DUNS 688999370

FDA Registration(s)

• Registration Number: 3011530718
• FEI Number: 3011530718
• Name: OSTEONIC CO., LTD.
• Owner & Operator: OSTEONIC Co., Ltd.
• Contact Address: 505-2, 505-3, 1201, 1206, 1207Ho, 38, Digital-ro 29-gil, Guro-gu; Seoul KR-NOTA 152-779 KR
• Official Correspondent:
  • Dong Won Lee
  • 82-2-69028400-x
• US Agent:
  • David Hyun Jun Paek
  • 818 9030660
  • dpaek.rennes@gmail.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 303, 405, 505-2, 505-3, 902, 1004, 1201, 1202, 1206Ho, 38, Digit Guro-gu; Seoul Seoul Teugbyeolsi, 08381 KR
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
GUDID 08800071020929 OSTEONIC CO.,Ltd.	VEGA	2023-02-17
GUDID 08800071020912 OSTEONIC CO.,Ltd.	VEGA	2023-02-17
GUDID 08800071020905 OSTEONIC CO.,Ltd.	VEGA	2023-02-17
GUDID 08800071020899 OSTEONIC CO.,Ltd.	VEGA	2023-02-17
GUDID 08800071020882 OSTEONIC CO.,Ltd.	VEGA	2023-02-17
GUDID 08800071020875 OSTEONIC CO.,Ltd.	VEGA	2023-02-17
GUDID 08800071020868 OSTEONIC CO.,Ltd.	VEGA	2023-02-17
GUDID 08800071020851 OSTEONIC CO.,Ltd.	VEGA	2023-02-17
GUDID 08800071020844 OSTEONIC CO.,Ltd.	VEGA	2023-02-17
GUDID 08800071020837 OSTEONIC CO.,Ltd.	VEGA	2023-02-17
GUDID 08800071020820 OSTEONIC CO.,Ltd.	VEGA	2023-02-17
GUDID 08800071020813 OSTEONIC CO.,Ltd.	VEGA	2023-02-17
GUDID 08800071020806 OSTEONIC CO.,Ltd.	VEGA	2023-02-17
GUDID 08800071020790 OSTEONIC CO.,Ltd.	VEGA	2023-02-17
PMN K210360 Osteonic Co., Ltd	Neuro Plating System, Neuro Plating System Plates(NST304M02A And 61 Models), Neuro Plating System-Packaging Unit(NSP-001 And 10 Models), Neuro Plating System-Sterile Kit(TCN-011 And 69 Models), Neuro Plating System-Screws(N15A03 And 11 Models)	2022-01-27
PMN K211992 Osteonic Co., Ltd.	Ortho MI System	2021-10-15
PMN K210122 Osteonic Co., Ltd.	Sterile Bioabsorbable Bone Screw (Bioabsorbable ACL Screw)	2021-08-27
GUDID 08809595975616 OSTEONIC CO.,Ltd.	Genie RCR Instruments	2021-07-29
GUDID 08809595975609 OSTEONIC CO.,Ltd.	Genie RCR Instruments	2021-07-29
GUDID 08809595975593 OSTEONIC CO.,Ltd.	Genie RCR Instruments	2021-07-29
GUDID 08809595975531 OSTEONIC CO.,Ltd.	Genie RCR Instruments	2021-07-29
GUDID 08809595975517 OSTEONIC CO.,Ltd.	Genie RCR Instruments	2021-07-29
GUDID 08809399748676 OSTEONIC CO.,Ltd.	Neo Advance Instruments	2021-07-29
GUDID 08809399748560 OSTEONIC CO.,Ltd.	Genie RCR Instruments	2021-07-29
GUDID 08809399748553 OSTEONIC CO.,Ltd.	Genie RCR Instruments	2021-07-29
GUDID 08809399748546 OSTEONIC CO.,Ltd.	Genie RCR Instruments	2021-07-29
GUDID 08809399748539 OSTEONIC CO.,Ltd.	Genie RCR Instruments	2021-07-29
GUDID 08800071020967 OSTEONIC CO.,Ltd.	Neo Advance Instruments	2021-07-29
GUDID 08800071020950 OSTEONIC CO.,Ltd.	Genie Labral Instruments	2021-07-29
GUDID 08800071020943 OSTEONIC CO.,Ltd.	Genie Labral Instruments	2021-07-29
GUDID 08800071020936 OSTEONIC CO.,Ltd.	Genie Labral Instruments	2021-07-29
GUDID 08800071018780 OSTEONIC CO.,Ltd.	Fix2Lock	2021-07-14
GUDID 08800071018773 OSTEONIC CO.,Ltd.	Fix2Lock	2021-07-14
GUDID 08800071018766 OSTEONIC CO.,Ltd.	Fix2Lock	2021-07-14
GUDID 08800071018759 OSTEONIC CO.,Ltd.	Fix2Lock	2021-07-14
GUDID 08800071018742 OSTEONIC CO.,Ltd.	Fix2Lock	2021-07-14
GUDID 08800071018735 OSTEONIC CO.,Ltd.	Fix2Lock	2021-07-14
GUDID 08800071018728 OSTEONIC CO.,Ltd.	Fix2Lock	2021-07-14
GUDID 08800071018711 OSTEONIC CO.,Ltd.	Fix2Lock	2021-07-14
GUDID 08800071018704 OSTEONIC CO.,Ltd.	Fix2Lock	2021-07-14
GUDID 08800071018698 OSTEONIC CO.,Ltd.	Fix2Lock	2021-07-14
GUDID 08800071018681 OSTEONIC CO.,Ltd.	Fix2Lock	2021-07-14
GUDID 08800071018674 OSTEONIC CO.,Ltd.	Fix2Lock	2021-07-14
GUDID 08800071018667 OSTEONIC CO.,Ltd.	Fix2Lock	2021-07-14
GUDID 08800071018650 OSTEONIC CO.,Ltd.	Fix2Lock	2021-07-14
GUDID 08800071018643 OSTEONIC CO.,Ltd.	Fix2Lock	2021-07-14
GUDID 08800071018636 OSTEONIC CO.,Ltd.	Fix2Lock	2021-07-14
GUDID 08800071018629 OSTEONIC CO.,Ltd.	Fix2Lock	2021-07-14
GUDID 08800071018612 OSTEONIC CO.,Ltd.	Fix2Lock	2021-07-14
GUDID 08800071018605 OSTEONIC CO.,Ltd.	Fix2Lock	2021-07-14
GUDID 08800071018599 OSTEONIC CO.,Ltd.	Fix2Lock	2021-07-14
GUDID 08800071018315 OSTEONIC CO.,Ltd.	Fix2Lock	2021-07-14
GUDID 08800071019039 OSTEONIC CO.,Ltd.	Sterile bone screw	2021-07-13
GUDID 08800071019022 OSTEONIC CO.,Ltd.	Sterile bone screw	2021-07-13
GUDID 08800071019015 OSTEONIC CO.,Ltd.	Sterile bone screw	2021-07-13
GUDID 08800071019008 OSTEONIC CO.,Ltd.	Sterile bone screw	2021-07-13
GUDID 08800071018308 OSTEONIC CO.,Ltd.	Fix2Lock	2021-07-13
GUDID 08800071018292 OSTEONIC CO.,Ltd.	Fix2Lock	2021-07-13
GUDID 08800071018285 OSTEONIC CO.,Ltd.	Fix2Lock	2021-07-13
GUDID 08800071018254 OSTEONIC CO.,Ltd.	Fix2Lock	2021-07-13
GUDID 08800071012696 OSTEONIC CO.,Ltd.	Fix2Lock	2021-07-13
GUDID 08800071012689 OSTEONIC CO.,Ltd.	Fix2Lock	2021-07-13
GUDID 08800071012672 OSTEONIC CO.,Ltd.	Fix2Lock	2021-07-13
GUDID 08800071012665 OSTEONIC CO.,Ltd.	Fix2Lock	2021-07-13
GUDID 08800071012658 OSTEONIC CO.,Ltd.	Fix2Lock	2021-07-13
GUDID 08800071012641 OSTEONIC CO.,Ltd.	Fix2Lock	2021-07-13
GUDID 08800071012634 OSTEONIC CO.,Ltd.	Fix2Lock	2021-07-13
GUDID 08800071012627 OSTEONIC CO.,Ltd.	Fix2Lock	2021-07-13
GUDID 08800071012610 OSTEONIC CO.,Ltd.	Fix2Lock	2021-07-13
GUDID 08800071012597 OSTEONIC CO.,Ltd.	Fix2Lock	2021-07-13
GUDID 08800071006787 OSTEONIC CO.,Ltd.	Fix2Lock	2021-07-13
GUDID 08800071006770 OSTEONIC CO.,Ltd.	Fix2Lock	2021-07-13
GUDID 08800071006763 OSTEONIC CO.,Ltd.	Fix2Lock	2021-07-13
GUDID 08800071006756 OSTEONIC CO.,Ltd.	Fix2Lock	2021-07-13
GUDID 08800071006749 OSTEONIC CO.,Ltd.	Fix2Lock	2021-07-13
GUDID 08800071006732 OSTEONIC CO.,Ltd.	Fix2Lock	2021-07-13
GUDID 08800071006725 OSTEONIC CO.,Ltd.	Fix2Lock	2021-07-13
GUDID 08800071006718 OSTEONIC CO.,Ltd.	Fix2Lock	2021-07-13
GUDID 08800071006701 OSTEONIC CO.,Ltd.	Fix2Lock	2021-07-13
GUDID 08800071006688 OSTEONIC CO.,Ltd.	Fix2Lock	2021-07-13
GUDID 08800071006671 OSTEONIC CO.,Ltd.	Fix2Lock	2021-07-13
GUDID 08800071006664 OSTEONIC CO.,Ltd.	Fix2Lock	2021-07-13
GUDID 08800071006657 OSTEONIC CO.,Ltd.	Fix2Lock	2021-07-13
GUDID 08800071006640 OSTEONIC CO.,Ltd.	Fix2Lock	2021-07-13
GUDID 08800071006633 OSTEONIC CO.,Ltd.	Fix2Lock	2021-07-13
GUDID 08800071006626 OSTEONIC CO.,Ltd.	Fix2Lock	2021-07-13
GUDID 08800071006619 OSTEONIC CO.,Ltd.	Fix2Lock	2021-07-13
GUDID 08800071006602 OSTEONIC CO.,Ltd.	Fix2Lock	2021-07-13
GUDID 08800071006596 OSTEONIC CO.,Ltd.	Fix2Lock	2021-07-13
GUDID 08800071006589 OSTEONIC CO.,Ltd.	Fix2Lock	2021-07-13
GUDID 08800071006572 OSTEONIC CO.,Ltd.	Fix2Lock	2021-07-13
GUDID 08800071006565 OSTEONIC CO.,Ltd.	Fix2Lock	2021-07-13
GUDID 08800071006558 OSTEONIC CO.,Ltd.	Fix2Lock	2021-07-13
GUDID 08800071006541 OSTEONIC CO.,Ltd.	Fix2Lock	2021-07-13
GUDID 08800071006534 OSTEONIC CO.,Ltd.	Fix2Lock	2021-07-13
GUDID 08800071006527 OSTEONIC CO.,Ltd.	Fix2Lock	2021-07-13
GUDID 08800071006510 OSTEONIC CO.,Ltd.	Fix2Lock	2021-07-13
GUDID 08800071006503 OSTEONIC CO.,Ltd.	Fix2Lock	2021-07-13
GUDID 08800071006497 OSTEONIC CO.,Ltd.	Fix2Lock	2021-07-13
GUDID 08800071006480 OSTEONIC CO.,Ltd.	Fix2Lock	2021-07-13
GUDID 08800071006473 OSTEONIC CO.,Ltd.	Fix2Lock	2021-07-13
GUDID 08800071006466 OSTEONIC CO.,Ltd.	Fix2Lock	2021-07-13
GUDID 08800071006459 OSTEONIC CO.,Ltd.	Fix2Lock	2021-07-13
PMN K202806 OSTEONIC Co., Ltd.	Fix2Lock (Biocomposite Medial, Biocomposite Lateral, Biocombi Self Punching)	2021-06-17
PMN K202663 Osteonic Co., Ltd.	Suture Wing	2021-06-07
PMN K202763 Osteonic Co., Ltd.	Fix2Lock (PEEK Self Punching)	2021-06-04
PMN K202883 Osteonic Co., Ltd.	Sterile Bone Screw (PEEK ACL Screw)	2020-11-25
PMN K190811 | HBW OSTEONIC CO., LTD.	NEURO PLATING SYSTEM	2019-12-27
PMN K190811 | GWO OSTEONIC CO., LTD.	NEURO PLATING SYSTEM	2019-12-27
PMN K190811 | GRX OSTEONIC CO., LTD.	NEURO PLATING SYSTEM	2019-12-27
PMN K190811 Osteonic Co., Ltd	Optimus NEURO System - Sterile Kit	2019-11-27
PMN K183352 | HBW OSTEONIC CO., LTD.	Neuro Plating System	2019-01-08
PMN K183352 | GXR OSTEONIC CO., LTD.	Neuro Plating System	2019-01-08
PMN K183352 | GWO OSTEONIC CO., LTD.	Neuro Plating System	2019-01-08
PMN K183352 Osteonic Co., Ltd	Optimus Neuro System	2019-01-02
KIJ OSTEONIC CO., LTD.	POWER SCREWDRIVER	2018-05-02
NBG OSTEONIC CO., LTD.	Pointer	2016-11-25
PMN K160363 OSTEONIC Co., Ltd.	OPTIMUS CMF SYSTEM	2016-10-20
HXX OSTEONIC CO., LTD.	Optimus CMF System - Screw driver body (various models)	2015-03-03
HXX OSTEONIC CO., LTD.	Optimus CMF System - Screw driver (various models)	2015-03-03
HXW OSTEONIC CO., LTD.	Optimus CMF System - Bending guide (various models)	2015-03-03
HXW OSTEONIC CO., LTD.	Optimus CMF System - Bender (various models)	2015-03-03
HXW OSTEONIC CO., LTD.	Neuro Plating System-Bender (various models)	2015-03-03
HTW OSTEONIC CO., LTD.	Optimus CMF System - Trocar set (various models)	2015-03-03
HTW OSTEONIC CO., LTD.	Optimus CMF System - Surgical drill bit-non power (various models)	2015-03-03
HTW OSTEONIC CO., LTD.	Optimus CMF System - Drill guide (various models)	2015-03-03
HTJ OSTEONIC CO., LTD.	Optimus CMF System - Depth gauge (various models)	2015-03-03
HTD OSTEONIC CO., LTD.	Optimus CMF System - Forceps (various models)	2015-03-03
HTD OSTEONIC CO., LTD.	Neuro Plating System- Forceps (various models)	2015-03-03
HTD OSTEONIC CO., LTD.	Forceps (various models)	2015-03-03
GXL OSTEONIC CO., LTD.	Neuro Plating System ? Screw driver body (various models)	2015-03-03
GXL OSTEONIC CO., LTD.	Neuro Plating System ? Screw driver (various models)	2015-03-03
FZT OSTEONIC CO., LTD.	Optimus Neuro System - Surgical cutter (various models)	2015-03-03
FZT OSTEONIC CO., LTD.	Optimus CMF System - Surgical cutter (various models)	2015-03-03
FSM OSTEONIC CO., LTD.	Tray (various models)	2015-03-03
PMN K141911 OSTEONIC CO., LTD.	OPTIMUS NEURO SYSTEM	2015-02-10
PMN K141911 | HBW OSTEONIC CO., LTD.	Neuro Plating System	2015-02-10
PMN K141911 | GXR OSTEONIC CO., LTD.	Neuro Plating System	2015-02-10
PMN K141911 | GWO OSTEONIC CO., LTD.	Neuro Plating System	2015-02-10
PMN K140037 | JEY OSTEONIC CO., LTD.	OPTIMUS CMF System	2015-02-10
PMN K140037 | DZL OSTEONIC CO., LTD.	OPTIMUS CMF System	2015-02-10
PMN K140037 OSTEONIC CO., LTD.	OPTIMUS CMF SYSTEM	2015-01-20