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MiRus, LLC

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
23
Inspections
2
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K252733ATLAS™ Expandable Osteotomy Wedge SystemFebruary 19, 2026
K242516EUROPA™ Posterior Cervical Fusion SystemNovember 19, 2024
K241175MiRus MoRe Lumbar Plating SystemMay 17, 2024
K232348RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion SystemOctober 27, 2023
K232481RIGEL™ 3DR Anterior Cervical Corpectomy SystemOctober 13, 2023
K232154MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate FixationSeptember 11, 2023
K230369EUROPA™ Navigated InstrumentsJune 23, 2023
K220441CYGNUS™ MoRe Anterior Cervical Plate SystemSeptember 16, 2022
K220115ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion SystemMay 13, 2022
K210800IO Expandable Lumbar Interbody Fusion SystemAugust 20, 2021
K200685RIGEL 3DR Anterior Cervical Interbody Fusion SystemJune 11, 2020
K191906MiRus 3D Printed Lumbar Interbody Fusion Systems consisting of the Callisto 3D Printed PLIF, HYPERIOMay 18, 2020
K191867ATLAS Plating SystemApril 9, 2020
K192268Europa Pedicle Screw SystemOctober 22, 2019
K191757EUROPA Pedicle Screw SystemJuly 19, 2019
K182524GALILEO Spine Alignment Monitoring SystemJune 17, 2019
K190618RIGEL PEEK Anterior Cervical Interbody Fusion SystemJune 6, 2019
K190666CYGNUS™ Anterior Cervical Plate SystemMay 9, 2019
K190415ATLAS Plating SystemApril 19, 2019
K180337EUROPA Pedicle Screw SystemMarch 14, 2019