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 OFKOREA EXCHANGE (KOSDAQ)226400DUNS 688999370
FDA Registration(s)
Registration Number3011530718
FEI Number3011530718
NameOSTEONIC CO., LTD.
Owner & OperatorOSTEONIC Co., Ltd.
Contact Address505-2, 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
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address303, 405, 505-2, 505-3, 902, 1004, 1201, 1202, 1206Ho, 38, Digit Guro-gu
Seoul Seoul Teugbyeolsi, 08381 KR
Establishment TypeManufacture Medical Device



FDA Filings

Device
Company
DeviceDate
Osteonic Co., Ltd.
Fix2Lock (PEEK Self Punching)2021-06-04
Osteonic Co., Ltd.
Sterile Bone Screw (PEEK ACL Screw)2020-11-25
OSTEONIC CO.,Ltd.
Neuro Plating System 2020-02-05
OSTEONIC CO.,Ltd.
Neuro Plating System 2020-02-05
OSTEONIC CO.,Ltd.
Neuro Plating System 2020-02-05
OSTEONIC CO.,Ltd.
Neuro Plating System 2020-02-05
OSTEONIC CO.,Ltd.
Neuro Plating System 2020-02-05
OSTEONIC CO.,Ltd.
Neuro Plating System 2020-02-05
OSTEONIC CO.,Ltd.
Neuro Plating System 2020-02-05
OSTEONIC CO.,Ltd.
Neuro Plating System 2020-02-05
OSTEONIC CO.,Ltd.
Neuro Plating System 2020-02-05
OSTEONIC CO.,Ltd.
Neuro Plating System 2020-02-05
OSTEONIC CO.,Ltd.
Neuro Plating System 2020-02-05
OSTEONIC CO.,Ltd.
Neuro Plating System 2020-02-05
OSTEONIC CO.,Ltd.
Neuro Plating System 2020-02-05
OSTEONIC CO.,Ltd.
Neuro Plating System 2020-02-05
OSTEONIC CO.,Ltd.
Neuro Plating System 2020-02-05
OSTEONIC CO.,Ltd.
Neuro Plating System 2020-02-05
OSTEONIC CO.,Ltd.
Neuro Plating System 2020-02-05
OSTEONIC CO.,Ltd.
Neuro Plating System 2020-02-05
OSTEONIC CO.,Ltd.
Neuro Plating System 2020-02-05
OSTEONIC CO.,Ltd.
Neuro Plating System 2020-02-05
OSTEONIC CO.,Ltd.
Neuro Plating System 2020-02-05
OSTEONIC CO.,Ltd.
Neuro Plating System 2020-02-05
OSTEONIC CO.,Ltd.
Neuro Plating System 2020-02-05
OSTEONIC CO.,Ltd.
Neuro Plating System 2020-02-05
OSTEONIC CO.,Ltd.
Neuro Plating System 2020-02-05
OSTEONIC CO.,Ltd.
Neuro Plating System 2020-02-05
OSTEONIC CO.,Ltd.
Neuro Plating System 2020-02-05
OSTEONIC CO.,Ltd.
Neuro Plating System 2020-02-05
OSTEONIC CO.,Ltd.
Neuro Plating System 2020-02-05
OSTEONIC CO.,Ltd.
Neuro Plating System 2020-02-05
OSTEONIC CO.,Ltd.
Neuro Plating System 2020-02-05
OSTEONIC CO.,Ltd.
Neuro Plating System 2020-02-05
OSTEONIC CO.,Ltd.
Neuro Plating System 2020-02-05
OSTEONIC CO.,Ltd.
Neuro Plating System 2020-02-05
OSTEONIC CO.,Ltd.
Neuro Plating System 2020-02-05
OSTEONIC CO.,Ltd.
Neuro Plating System 2020-02-05
OSTEONIC CO.,Ltd.
Neuro Plating System 2020-02-05
OSTEONIC CO.,Ltd.
Neuro Plating System 2020-02-05
OSTEONIC CO.,Ltd.
Neuro Plating System 2020-02-05
OSTEONIC CO.,Ltd.
Neuro Plating System 2020-02-05
OSTEONIC CO.,Ltd.
Neuro Plating System 2020-02-05
OSTEONIC CO.,Ltd.
Neuro Plating System 2020-02-05
OSTEONIC CO.,Ltd.
Neuro Plating System 2020-02-05
OSTEONIC CO.,Ltd.
Neuro Plating System 2020-02-05
OSTEONIC CO.,Ltd.
Neuro Plating System 2020-02-05
OSTEONIC CO.,Ltd.
Neuro Plating System 2020-02-05
OSTEONIC CO.,Ltd.
Neuro Plating System 2020-02-05
OSTEONIC CO.,Ltd.
Neuro Plating System 2020-02-05
OSTEONIC CO.,Ltd.
Neuro Plating System 2020-02-05
OSTEONIC CO.,Ltd.
Neuro Plating System 2020-02-05
OSTEONIC CO.,Ltd.
Neuro Plating System 2020-02-05
OSTEONIC CO.,Ltd.
Neuro Plating System 2020-02-05
OSTEONIC CO.,Ltd.
Neuro Plating System 2020-02-05
OSTEONIC CO.,Ltd.
Neuro Plating System 2020-02-04
OSTEONIC CO.,Ltd.
Neuro Plating System 2020-01-07
OSTEONIC CO.,Ltd.
Neuro Plating System 2020-01-07
OSTEONIC CO.,Ltd.
Neuro Plating System 2020-01-07
OSTEONIC CO.,Ltd.
Neuro Plating System 2020-01-07
OSTEONIC CO.,Ltd.
Neuro Plating System 2020-01-07
OSTEONIC CO.,Ltd.
Neuro Plating System 2020-01-07
OSTEONIC CO.,Ltd.
Neuro Plating System 2020-01-07
OSTEONIC CO., LTD.
NEURO PLATING SYSTEM2019-12-27
OSTEONIC CO., LTD.
NEURO PLATING SYSTEM2019-12-27
OSTEONIC CO., LTD.
NEURO PLATING SYSTEM2019-12-27
Osteonic Co., Ltd
Optimus NEURO System - Sterile Kit2019-11-27
OSTEONIC CO.,Ltd.
Neuro Plating System 2019-06-06
OSTEONIC CO.,Ltd.
Neuro Plating System 2019-06-04
OSTEONIC CO.,Ltd.
Neuro Plating System 2019-06-04
OSTEONIC CO.,Ltd.
Neuro Plating System 2019-06-04
OSTEONIC CO.,Ltd.
Neuro Plating System 2019-06-04
OSTEONIC CO.,Ltd.
Neuro Plating System 2019-06-04
OSTEONIC CO.,Ltd.
Neuro Plating System 2019-06-04
OSTEONIC CO.,Ltd.
Neuro Plating System 2019-06-04
OSTEONIC CO.,Ltd.
Neuro Plating System 2019-06-04
OSTEONIC CO.,Ltd.
Neuro Plating System 2019-06-04
OSTEONIC CO.,Ltd.
Neuro Plating System 2019-06-04
OSTEONIC CO.,Ltd.
Neuro Plating System 2019-06-04
OSTEONIC CO., LTD.
Neuro Plating System2019-01-08
OSTEONIC CO., LTD.
Neuro Plating System2019-01-08
OSTEONIC CO., LTD.
Neuro Plating System2019-01-08
Osteonic Co., Ltd
Optimus Neuro System2019-01-02
OSTEONIC CO., LTD.
POWER SCREWDRIVER2018-05-02
OSTEONIC CO., LTD.
Pointer2016-11-25
OSTEONIC Co., Ltd.
OPTIMUS CMF SYSTEM2016-10-20
OSTEONIC CO., LTD.
Optimus CMF System - Screw driver body (various models)2015-03-03
OSTEONIC CO., LTD.
Optimus CMF System - Screw driver (various models)2015-03-03
OSTEONIC CO., LTD.
Optimus CMF System - Bending guide (various models)2015-03-03
OSTEONIC CO., LTD.
Optimus CMF System - Bender (various models)2015-03-03
OSTEONIC CO., LTD.
Neuro Plating System-Bender (various models)2015-03-03
OSTEONIC CO., LTD.
Optimus CMF System - Trocar set (various models)2015-03-03
OSTEONIC CO., LTD.
Optimus CMF System - Surgical drill bit-non power (various models)2015-03-03
OSTEONIC CO., LTD.
Optimus CMF System - Drill guide (various models)2015-03-03
OSTEONIC CO., LTD.
Optimus CMF System - Depth gauge (various models)2015-03-03
OSTEONIC CO., LTD.
Optimus CMF System - Forceps (various models)2015-03-03
OSTEONIC CO., LTD.
Neuro Plating System- Forceps (various models)2015-03-03
OSTEONIC CO., LTD.
Forceps (various models)2015-03-03
OSTEONIC CO., LTD.
Neuro Plating System ? Screw driver body (various models)2015-03-03
OSTEONIC CO., LTD.
Neuro Plating System ? Screw driver (various models)2015-03-03
OSTEONIC CO., LTD.
Optimus Neuro System - Surgical cutter (various models)2015-03-03
OSTEONIC CO., LTD.
Optimus CMF System - Surgical cutter (various models)2015-03-03
OSTEONIC CO., LTD.
Tray (various models)2015-03-03
OSTEONIC CO., LTD.
OPTIMUS NEURO SYSTEM2015-02-10
OSTEONIC CO., LTD.
Neuro Plating System2015-02-10
OSTEONIC CO., LTD.
Neuro Plating System2015-02-10
OSTEONIC CO., LTD.
Neuro Plating System2015-02-10
OSTEONIC CO., LTD.
OPTIMUS CMF System2015-02-10
OSTEONIC CO., LTD.
OPTIMUS CMF System2015-02-10
OSTEONIC CO., LTD.
OPTIMUS CMF SYSTEM2015-01-20

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