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OSTEONIC CO., Ltd.

South Korea·KR-MF-000008969

Last updated September 17, 2026

Information

Country: South Korea
Address: 405Ho, 505-2Ho, 505-3Ho, 508Ho, 603Ho, 706Ho, 902Ho, 1002Ho, 1004Ho, 1005Ho, 1103Ho, 12F, 38, Digital-ro 29-gil, Guro-gu, and 102Ho, 103Ho, 105Ho, 24, Digital-ro 27-gil, Guro-gu, 1012Ho, 1013Ho, 272, Digital-ro, Guro-gu, and 102Ho, 103Ho, 104-1Ho, 104-2Ho, 105Ho, 106Ho, 36, Digital-ro 27 gil, Guro-gu, Seoul, South Korea
Website: osteonic.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +82269028411
PRRC Contact: Chang ho Moon
EUDAMED SRN: KR-MF-000008969
FDA FEI Number: 3011530718
DUNS Number: 688999370

Catalogue (1863)

Page 37 of 38

Device	Model / Reference	Registries	Class	Status
Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching)	K243467	FDA 510(k)	Class II	Active
Optimus Cmf System	K140037	FDA 510(k)	Class II	Active
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)	K210360	FDA 510(k)	Class II	Active
Ortho MI System	K211992	FDA 510(k)	Class II	Active
Fix2Lock(PEEK Self Punching)	K231322	FDA 510(k)	Class II	Active
Fix2Lock(Biocomposite medial, lateral, Biocombi Self Punching)	K231326	FDA 510(k)	Class II	Active
Suture Wing	K202663	FDA 510(k)	Class II	Active
Optimus Cmf System	K160363	FDA 510(k)	Class II	Active
Optimus NEURO System - Sterile Kit	K190811	FDA 510(k)	Class II	Active
Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching)	K202806	FDA 510(k)	Class II	Active
Suture Wing	K233659	FDA 510(k)	Class II	Active
Fix2Lock (PEEK Self Punching)	K243470	FDA 510(k)	Class II	Active
Fix2Lock (PEEK Self Punching)	K202763	FDA 510(k)	Class II	Active
Signex	K243469	FDA 510(k)	Class II	Active
Optimus Neuro System	K141911	FDA 510(k)	Class II	Active
Sterile Bioabsorbable bone screw (Bioabsorbable ACL screw)	K210122	FDA 510(k)	Class II	Active
Sterile bone screw (PEEK ACL screw)	K202883	FDA 510(k)	Class II	Active
Aster	K254182	FDA 510(k)	Class II	Active
Optimus Neuro System	K183352	FDA 510(k)	Class II	Active
Signex	K230546	FDA 510(k)	Class II	Active
Non-sterile CMF (Cranio Maxillofacial Fixation) Instrument System	TPO-006	EUDAMED	Class I	Active
Non-sterile CMF (Cranio Maxillofacial Fixation) Instrument System	IOC-093	EUDAMED	Class I	Active
Non-sterile CMF (Cranio Maxillofacial Fixation) Instrument System	TSF-001	EUDAMED	Class I	Active
Reusable Surgical Instrument	BIS-2610-DR	EUDAMEDFDA UDI	Class I	Active
Non-sterile CMF (Cranio Maxillofacial Fixation) Instrument System	IOC-060	EUDAMED	Class I	Active
Non-sterile CMF (Cranio Maxillofacial Fixation) Instrument System	IOC-041	EUDAMEDFDA UDI	Class I	Active
Reusable Surgical Instrument	BLA-4750-PUNCH	EUDAMEDFDA UDI	Class I	Active
Non-sterile CMF (Cranio Maxillofacial Fixation) Instrument System	IOC-080	EUDAMED	Class I	Active
Reusable Surgical Instrument	BIS-04225-DG	EUDAMEDFDA UDI	Class I	Active
Non-sterile CMF (Cranio Maxillofacial Fixation) Instrument System	MDB-05	EUDAMED	Class I	Active
Reusable Surgical Instrument	BMA-5519-AWL	EUDAMEDFDA UDI	Class I	Active
Reusable Surgical Instrument	110045297	EUDAMED	Class I	Active
Reusable Surgical Instrument	110045296	EUDAMED	Class I	Active
Non-sterile CMF (Cranio Maxillofacial Fixation) Instrument System	IOC-150	EUDAMED	Class I	Active
Non-sterile CMF (Cranio Maxillofacial Fixation) Instrument System	ODB-01	EUDAMED	Class I	Active
Non-sterile CMF (Cranio Maxillofacial Fixation) Instrument System	TSO-001	EUDAMED	Class I	Active
Non-sterile CMF (Cranio Maxillofacial Fixation) Instrument System	TPN-005	EUDAMEDFDA UDI	Class I	Active
Reusable Surgical Instrument	110045275	EUDAMED	Class I	Active
Non-sterile CMF (Cranio Maxillofacial Fixation) Instrument System	IOC-091	EUDAMED	Class I	Active
Reusable Surgical Instrument	BHA-4820-AWL	EUDAMEDFDA UDI	Class I	Active
Non-sterile CMF (Cranio Maxillofacial Fixation) Instrument System	IOC-040	EUDAMEDFDA UDI	Class I	Active
Non-sterile CMF (Cranio Maxillofacial Fixation) Instrument System	TCM-003	EUDAMED	Class I	Active
Non-sterile CMF (Cranio Maxillofacial Fixation) Instrument System	IOC-132	EUDAMED	Class I	Active
Non-sterile CMF (Cranio Maxillofacial Fixation) Instrument System	LDS-01	EUDAMEDFDA UDI	Class I	Active
Reusable Surgical Instrument	110045261	EUDAMEDFDA UDI	Class I	Active
Non-sterile CMF (Cranio Maxillofacial Fixation) Instrument System	ODB-16	EUDAMED	Class I	Active
Reusable Surgical Instrument	110046508	EUDAMED	Class I	Active
Reusable Surgical Instrument	110045276	EUDAMED	Class I	Active
Reusable Surgical Instrument	110045278	EUDAMED	Class I	Active
Non-sterile CMF (Cranio Maxillofacial Fixation) Instrument System	IOC-110	EUDAMEDFDA UDI	Class I	Active

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Emergo Europe B.V. NL

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