MiRus, LLC

Code	Device name	Class	Specialty	Clearances	Most recent
OLO	Orthopedic Stereotaxic Instrument	Class II	Neurology	2	2026-03-18
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Class II	Orthopedic	2	2024-05-17
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Class II	Orthopedic	2	2023-09-11
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Class II	Orthopedic	2	2021-08-20
PLF	Bone Wedge	Class II	Orthopedic	1	2026-02-19
NKG	Posterior Cervical Screw System	Class II	Orthopedic	1	2024-11-19
OVE	Intervertebral Fusion Device With Integrated Fixation, Cervical	Class II	Orthopedic	1	2023-10-27
PLR	—	—	—	1	2023-10-13
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Class II	Orthopedic	1	2020-06-11
HRS	Plate, Fixation, Bone	Class II	Orthopedic	1	2020-04-09

Date	K-number	Device	Code	Class	Specialty
2026-03-18	K253444	EUROPA Posterior Cervical Fusion Navigated Instruments	OLO	Class II	Neurology
2026-02-19	K252733	ATLAS Expandable Osteotomy Wedge System	PLF	Class II	Orthopedic
2024-11-19	K242516	EUROPA Posterior Cervical Fusion System	NKG	Class II	Orthopedic
2024-05-17	K241175	MiRus MoRe Lumbar Plating System	KWQ	Class II	Orthopedic
2023-10-27	K232348	RIGEL 3DR Standalone Anterior Cervical Interbody Fusion System	OVE	Class II	Orthopedic
2023-10-13	K232481	RIGEL 3DR Anterior Cervical Corpectomy System	PLR	—	—
2023-09-11	K232154	MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate Fixation	OVD	Class II	Orthopedic
2023-06-23	K230369	EUROPA Navigated Instruments	OLO	Class II	Neurology
2022-09-16	K220441	CYGNUS MoRe Anterior Cervical Plate System	KWQ	Class II	Orthopedic
2022-05-13	K220115	ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion System	OVD	Class II	Orthopedic
2021-08-20	K210800	IO Expandable Lumbar Interbody Fusion System	MAX	Class II	Orthopedic
2020-06-11	K200685	RIGEL 3DR Anterior Cervical Interbody Fusion System	ODP	Class II	Orthopedic
2020-05-18	K191906	MiRus 3D Printed Lumbar Interbody Fusion Systems consisting of the Callisto 3D Printed PLIF, HYPERION 3D Printed TLIF, CALYPSO 3D Printed LLIF, and ANTARES 3D Printed ALIF	MAX	Class II	Orthopedic
2020-04-09	K191867	ATLAS Plating System	HRS	Class II	Orthopedic

Clearance cadence by quarter