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MiRus, LLC

FDA 510(k) & PMA Approved Devices — 24 products

Total Devices24
Categories12
Latest FDA decision2026-03-18
TypeNumberDevice NameCodeDateActions
510(k) K253444 EUROPA™ Posterior Cervical Fusion Navigated InstrumentsOLO2026-03-18 View
510(k) K252733 ATLAS™ Expandable Osteotomy Wedge SystemPLF2026-02-19 View
510(k) K242516 EUROPA™ Posterior Cervical Fusion SystemNKG2024-11-19 View
510(k) K241175 MiRus MoRe Lumbar Plating SystemKWQ2024-05-17 View
510(k) K232348 RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion SystemOVE2023-10-27 View
510(k) K232481 RIGEL™ 3DR Anterior Cervical Corpectomy SystemPLR2023-10-13 View
510(k) K232154 MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate FixationOVD2023-09-11 View
510(k) K230369 EUROPA™ Navigated InstrumentsOLO2023-06-23 View
510(k) K220441 CYGNUS™ MoRe Anterior Cervical Plate SystemKWQ2022-09-16 View
510(k) K220115 ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion SystemOVD2022-05-13 View
510(k) K210800 IO Expandable Lumbar Interbody Fusion SystemMAX2021-08-20 View
510(k) K200685 RIGEL 3DR Anterior Cervical Interbody Fusion SystemODP2020-06-11 View
510(k) 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 ALIFMAX2020-05-18 View
510(k) K191867 ATLAS Plating SystemHRS2020-04-09 View
510(k) K192268 Europa Pedicle Screw SystemNKB2019-10-22 View
510(k) K191757 EUROPA Pedicle Screw SystemNKB2019-07-19 View
510(k) K182524 GALILEO Spine Alignment Monitoring SystemOLO2019-06-17 View
510(k) K190618 RIGEL PEEK Anterior Cervical Interbody Fusion SystemODP2019-06-06 View
510(k) K190666 CYGNUS™ Anterior Cervical Plate SystemKWQ2019-05-09 View
510(k) K190415 ATLAS Plating SystemHRS2019-04-19 View

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