Company · KR

Osteonic Co., Ltd.

FDA 510(k) clearances and medical device recalls filed under this name, 2015 to 2026. Name variants (Inc, Corp, punctuation) are merged.

20510(k) clearances (1 in 12 months)

0recalls (0 in 12 months)

0recalls that name a 510(k)

Product codes

Code	Device	Records
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	6
GWO	Plate, Cranioplasty, Preformed, Alterable	4
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	4
HRS	Plate, Fixation, Bone	2
JEY	Plate, Bone	2
KWQ	Appliance, Fixation, Spinal Intervertebral Body	1
OAT	Implant, Endosseous, Orthodontic	1

Latest 510(k) clearances

Decided	510(k)	Device and applicant	Code
Feb 26, 2026	K254182	Aster Osteonic Co., Ltd., KR	KWQ
May 29, 2025	K243469	SIGNEX Osteonic Co., Ltd., KR	HRS
Dec 3, 2024	K243470	Fix2Lock (PEEK Self Punching) Osteonic Co., Ltd., KR	MBI
Dec 3, 2024	K243467	Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching) Osteonic Co., Ltd., KR	MAI
Jun 11, 2024	K230546	SIGNEX Osteonic Co., Ltd., KR	HRS
Dec 26, 2023	K233659	Suture Wing Osteonic Co., Ltd., KR	MBI
Jun 7, 2023	K231322	Fix2Lock(PEEK Self Punching) Osteonic Co., Ltd., KR	MBI
May 31, 2023	K231326	Fix2Lock(Biocomposite medial, lateral, Biocombi Self Punching) Osteonic Co., Ltd., KR	MAI
Jan 27, 2022	K210360	Neuro Plating System, Neuro Plating System Plates(NST304M02A and 61 Models), Neuro Plating System-Packaging unit(NSP-001 Osteonic Co., Ltd., KR	GWO
Oct 15, 2021	K211992	Ortho MI System Osteonic Co., Ltd., KR	OAT
Aug 27, 2021	K210122	Sterile Bioabsorbable bone screw (Bioabsorbable ACL screw) Osteonic Co., Ltd., KR	MAI
Jun 17, 2021	K202806	Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching) Osteonic Co., Ltd., KR	MAI
Jun 7, 2021	K202663	Suture Wing Osteonic Co., Ltd., KR	MBI
Jun 4, 2021	K202763	Fix2Lock (PEEK Self Punching) Osteonic Co., Ltd., KR	MBI
Nov 25, 2020	K202883	Sterile bone screw (PEEK ACL screw) Osteonic Co., Ltd., KR	MBI
Nov 27, 2019	K190811	Optimus NEURO System - Sterile Kit Osteonic Co., Ltd., KR	GWO
Jan 2, 2019	K183352	Optimus Neuro System Osteonic Co., Ltd., KR	GWO
Oct 20, 2016	K160363	OPTIMUS CMF SYSTEM Osteonic Co., Ltd., KR	JEY
Feb 10, 2015	K141911	OPTIMUS NEURO SYSTEM Osteonic Co., Ltd.	GWO
Jan 20, 2015	K140037	OPTIMUS CMF SYSTEM Osteonic Co., Ltd., KR	JEY

Latest recalls

Date	Firm and product	Code	Linked 510(k)
No recalls in this window.

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