MiRus, LLC - FDA 510(k) Cleared Devices
Recent clearances: EUROPA™ Posterior Cervical Fusion Navigated Instruments, ATLAS™ Expandable Osteotomy Wedge System, EUROPA™ Posterior Cervical Fusion System
24
Total
24
Cleared
0
Denied
FDA 510(k) Regulatory Record - MiRus, LLC Orthopedic ✕
24 devices
Cleared
Mar 18, 2026
EUROPA™ Posterior Cervical Fusion Navigated Instruments
Orthopedic
167d
Cleared
Feb 19, 2026
ATLAS™ Expandable Osteotomy Wedge System
Orthopedic
175d
Cleared
Nov 19, 2024
EUROPA™ Posterior Cervical Fusion System
Orthopedic
88d
Cleared
May 17, 2024
MiRus MoRe Lumbar Plating System
Orthopedic
21d
Cleared
Oct 27, 2023
RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion System
Orthopedic
81d
Cleared
Oct 13, 2023
RIGEL™ 3DR Anterior Cervical Corpectomy System
Orthopedic
58d
Cleared
Sep 11, 2023
MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate Fixation
Orthopedic
53d
Cleared
Jun 23, 2023
EUROPA™ Navigated Instruments
Orthopedic
133d
Cleared
Sep 16, 2022
CYGNUS™ MoRe Anterior Cervical Plate System
Orthopedic
212d
Cleared
May 13, 2022
ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion System
Orthopedic
119d
Cleared
Aug 20, 2021
IO Expandable Lumbar Interbody Fusion System
Orthopedic
157d
Cleared
Jun 11, 2020
RIGEL 3DR Anterior Cervical Interbody Fusion System
Orthopedic
87d