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 08809416064659 OSTEONIC CO.,Ltd.	Signex	2025-07-09
GUDID 08809416064642 OSTEONIC CO.,Ltd.	Signex	2025-07-09
GUDID 08809416064635 OSTEONIC CO.,Ltd.	Signex	2025-07-09
GUDID 08809416064628 OSTEONIC CO.,Ltd.	Signex	2025-07-09
GUDID 08809416064611 OSTEONIC CO.,Ltd.	Signex	2025-07-09
GUDID 08809416064604 OSTEONIC CO.,Ltd.	Signex	2025-07-09
GUDID 08809416064598 OSTEONIC CO.,Ltd.	Signex	2025-07-09
GUDID 08809416064581 OSTEONIC CO.,Ltd.	Signex	2025-07-09
GUDID 08809399749291 OSTEONIC CO.,Ltd.	Signex	2025-07-09
GUDID 08809399749154 OSTEONIC CO.,Ltd.	Signex	2025-07-09
GUDID 08800071034421 OSTEONIC CO.,Ltd.	Signex	2025-07-09
GUDID 08800071034414 OSTEONIC CO.,Ltd.	Signex	2025-07-09
GUDID 08800071034407 OSTEONIC CO.,Ltd.	Signex	2025-07-09
GUDID 08800071034391 OSTEONIC CO.,Ltd.	Signex	2025-07-09
GUDID 08800071034384 OSTEONIC CO.,Ltd.	Signex	2025-07-09
GUDID 08800071034377 OSTEONIC CO.,Ltd.	Signex	2025-07-09
GUDID 08800071034360 OSTEONIC CO.,Ltd.	Signex	2025-07-09
GUDID 08800071034353 OSTEONIC CO.,Ltd.	Signex	2025-07-09
GUDID 08800071034322 OSTEONIC CO.,Ltd.	Signex	2025-07-09
GUDID 08800071034315 OSTEONIC CO.,Ltd.	Signex	2025-07-09
GUDID 08800071034308 OSTEONIC CO.,Ltd.	Signex	2025-07-09
GUDID 08800071034292 OSTEONIC CO.,Ltd.	Signex	2025-07-09
GUDID 08800071034285 OSTEONIC CO.,Ltd.	Signex	2025-07-09
GUDID 08800071034278 OSTEONIC CO.,Ltd.	Signex	2025-07-09
GUDID 08800071034261 OSTEONIC CO.,Ltd.	Signex	2025-07-09
GUDID 08800071033943 OSTEONIC CO.,Ltd.	Signex	2025-07-09
GUDID 08800071033936 OSTEONIC CO.,Ltd.	Signex	2025-07-09
GUDID 08800071033929 OSTEONIC CO.,Ltd.	Signex	2025-07-09
GUDID 08800071033912 OSTEONIC CO.,Ltd.	Signex	2025-07-09
GUDID 08800071033905 OSTEONIC CO.,Ltd.	Signex	2025-07-09
GUDID 08800071023319 OSTEONIC CO.,Ltd.	Signex	2025-07-09
GUDID 08800071023302 OSTEONIC CO.,Ltd.	Signex	2025-07-09
GUDID 08800071023296 OSTEONIC CO.,Ltd.	Signex	2025-07-09
GUDID 08800071023289 OSTEONIC CO.,Ltd.	Signex	2025-07-09
GUDID 08800071023272 OSTEONIC CO.,Ltd.	Signex	2025-07-09
GUDID 08800071023265 OSTEONIC CO.,Ltd.	Signex	2025-07-09
GUDID 08800071023258 OSTEONIC CO.,Ltd.	Signex	2025-07-09
GUDID 08800071023241 OSTEONIC CO.,Ltd.	Signex	2025-07-09
GUDID 08800071023234 OSTEONIC CO.,Ltd.	Signex	2025-07-09
GUDID 08800071023227 OSTEONIC CO.,Ltd.	Signex	2025-07-09
GUDID 08800071023210 OSTEONIC CO.,Ltd.	Signex	2025-07-09
GUDID 08800071023203 OSTEONIC CO.,Ltd.	Signex	2025-07-09
GUDID 08800071023197 OSTEONIC CO.,Ltd.	Signex	2025-07-09
GUDID 08800071023180 OSTEONIC CO.,Ltd.	Signex	2025-07-09
GUDID 08800071023173 OSTEONIC CO.,Ltd.	Signex	2025-07-09
GUDID 08800071023166 OSTEONIC CO.,Ltd.	Signex	2025-07-09
GUDID 08800071023159 OSTEONIC CO.,Ltd.	Signex	2025-07-09
GUDID 08800071023142 OSTEONIC CO.,Ltd.	Signex	2025-07-09
GUDID 08800071023135 OSTEONIC CO.,Ltd.	Signex	2025-07-09
GUDID 08800071023128 OSTEONIC CO.,Ltd.	Signex	2025-07-09
GUDID 08800071023111 OSTEONIC CO.,Ltd.	Signex	2025-07-09
GUDID 08800071023104 OSTEONIC CO.,Ltd.	Signex	2025-07-09
GUDID 08800071023098 OSTEONIC CO.,Ltd.	Signex	2025-07-09
GUDID 08800071023081 OSTEONIC CO.,Ltd.	Signex	2025-07-09
GUDID 08800071023074 OSTEONIC CO.,Ltd.	Signex	2025-07-09
GUDID 08800071023067 OSTEONIC CO.,Ltd.	Signex	2025-07-09
GUDID 08800071023050 OSTEONIC CO.,Ltd.	Signex	2025-07-09
GUDID 08800071023043 OSTEONIC CO.,Ltd.	Signex	2025-07-09
GUDID 08800071023036 OSTEONIC CO.,Ltd.	Signex	2025-07-09
GUDID 08800071023029 OSTEONIC CO.,Ltd.	Signex	2025-07-09
GUDID 08800071023012 OSTEONIC CO.,Ltd.	Signex	2025-07-09
GUDID 08800071023005 OSTEONIC CO.,Ltd.	Signex	2025-07-09
GUDID 08800071022992 OSTEONIC CO.,Ltd.	Signex	2025-07-09
GUDID 08800071022985 OSTEONIC CO.,Ltd.	Signex	2025-07-09
GUDID 08800071022978 OSTEONIC CO.,Ltd.	Signex	2025-07-09
GUDID 08800071022961 OSTEONIC CO.,Ltd.	Signex	2025-07-09
GUDID 08800071022954 OSTEONIC CO.,Ltd.	Signex	2025-07-09
GUDID 08800071022947 OSTEONIC CO.,Ltd.	Signex	2025-07-09
GUDID 08800071022930 OSTEONIC CO.,Ltd.	Signex	2025-07-09
GUDID 08800071022923 OSTEONIC CO.,Ltd.	Signex	2025-07-09
GUDID 08800071022916 OSTEONIC CO.,Ltd.	Signex	2025-07-09
GUDID 08800071022909 OSTEONIC CO.,Ltd.	Signex	2025-07-09
GUDID 08800071022893 OSTEONIC CO.,Ltd.	Signex	2025-07-09
GUDID 08800071022688 OSTEONIC CO.,Ltd.	Signex	2025-07-09
GUDID 08800071022671 OSTEONIC CO.,Ltd.	Signex	2025-07-09
GUDID 08800071022664 OSTEONIC CO.,Ltd.	Signex	2025-07-09
GUDID 08800071022657 OSTEONIC CO.,Ltd.	Signex	2025-07-09
GUDID 08800071022640 OSTEONIC CO.,Ltd.	Signex	2025-07-09
GUDID 08800071022633 OSTEONIC CO.,Ltd.	Signex	2025-07-09
GUDID 08800071022626 OSTEONIC CO.,Ltd.	Signex	2025-07-09
GUDID 08800071022619 OSTEONIC CO.,Ltd.	Signex	2025-07-09
GUDID 08800071022602 OSTEONIC CO.,Ltd.	Signex	2025-07-09
GUDID 08800071022596 OSTEONIC CO.,Ltd.	Signex	2025-07-09
GUDID 08800071022589 OSTEONIC CO.,Ltd.	Signex	2025-07-09
GUDID 08800071022572 OSTEONIC CO.,Ltd.	Signex	2025-07-09
GUDID 08800071022565 OSTEONIC CO.,Ltd.	Signex	2025-07-09
GUDID 08800071022558 OSTEONIC CO.,Ltd.	Signex	2025-07-09
GUDID 08800071022541 OSTEONIC CO.,Ltd.	Signex	2025-07-09
GUDID 08800071022534 OSTEONIC CO.,Ltd.	Signex	2025-07-09
GUDID 08800071022527 OSTEONIC CO.,Ltd.	Signex	2025-07-09
GUDID 08800071022510 OSTEONIC CO.,Ltd.	Signex	2025-07-09
GUDID 08800071022503 OSTEONIC CO.,Ltd.	Signex	2025-07-09
GUDID 08800071022497 OSTEONIC CO.,Ltd.	Signex	2025-07-09
GUDID 08800071022480 OSTEONIC CO.,Ltd.	Signex	2025-07-09
GUDID 08800071022473 OSTEONIC CO.,Ltd.	Signex	2025-07-09
GUDID 08800071004301 OSTEONIC CO.,Ltd.	Signex	2025-07-09
GUDID 08800071004295 OSTEONIC CO.,Ltd.	Signex	2025-07-09
GUDID 08800071001553 OSTEONIC CO.,Ltd.	Signex	2025-07-09
GUDID 08800071001546 OSTEONIC CO.,Ltd.	Signex	2025-07-09
GUDID 08800071001539 OSTEONIC CO.,Ltd.	Signex	2025-07-09
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
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