Osteonic Co., Ltd.

Code	Device name	Class	Specialty	Clearances	Most recent
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Class II	Orthopedic	6	2024-12-03
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Class II	Orthopedic	4	2024-12-03
HRS	Plate, Fixation, Bone	Class II	Orthopedic	2	2025-05-29
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Class II	Orthopedic	1	2026-02-26
GWO	Plate, Cranioplasty, Preformed, Alterable	Class II	Neurology	1	2022-01-27
OAT	Implant, Endosseous, Orthodontic	Class II	Dental	1	2021-10-15

Date	K-number	Device	Code	Class	Specialty
2026-02-26	K254182	Aster	KWQ	Class II	Orthopedic
2025-05-29	K243469	SIGNEX	HRS	Class II	Orthopedic
2024-12-03	K243470	Fix2Lock (PEEK Self Punching)	MBI	Class II	Orthopedic
2024-12-03	K243467	Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching)	MAI	Class II	Orthopedic
2024-06-11	K230546	SIGNEX	HRS	Class II	Orthopedic
2023-12-26	K233659	Suture Wing	MBI	Class II	Orthopedic
2023-06-07	K231322	Fix2Lock(PEEK Self Punching)	MBI	Class II	Orthopedic
2023-05-31	K231326	Fix2Lock(Biocomposite medial, lateral, Biocombi Self Punching)	MAI	Class II	Orthopedic
2022-01-27	K210360	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)	GWO	Class II	Neurology
2021-10-15	K211992	Ortho MI System	OAT	Class II	Dental
2021-08-27	K210122	Sterile Bioabsorbable bone screw (Bioabsorbable ACL screw)	MAI	Class II	Orthopedic
2021-06-17	K202806	Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching)	MAI	Class II	Orthopedic
2021-06-07	K202663	Suture Wing	MBI	Class II	Orthopedic
2021-06-04	K202763	Fix2Lock (PEEK Self Punching)	MBI	Class II	Orthopedic
2020-11-25	K202883	Sterile bone screw (PEEK ACL screw)	MBI	Class II	Orthopedic

Clearance cadence by quarter