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MiRus, LLC FDA Approvals

0 new drug approvals and 11 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product
EUROPA™ Posterior Cervical Fusion Navigated Instruments510(k)Mar 18, 2026Neurology
ATLAS™ Expandable Osteotomy Wedge System510(k)Feb 19, 2026Orthopedic
EUROPA™ Posterior Cervical Fusion System510(k)Nov 19, 2024Orthopedic
MiRus MoRe Lumbar Plating System510(k)May 17, 2024Orthopedic
RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion System510(k)Oct 27, 2023Orthopedic
RIGEL™ 3DR Anterior Cervical Corpectomy System510(k)Oct 13, 2023Orthopedic
MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate Fixation510(k)Sep 11, 2023Orthopedic
EUROPA™ Navigated Instruments510(k)Jun 23, 2023Neurology
CYGNUS™ MoRe Anterior Cervical Plate System510(k)Sep 16, 2022Orthopedic
ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion System510(k)May 13, 2022Orthopedic
IO Expandable Lumbar Interbody Fusion System510(k)Aug 20, 2021Orthopedic

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