MiRus, LLC
FDA 510(k) & PMA Approved Devices — 24 products
Total Devices24
Categories12
Latest Approval2026-03-18
| Type | Number | Device Name | Code | Date | |
|---|---|---|---|---|---|
| 510(k) | K253444 | EUROPA Posterior Cervical Fusion Navigated Instruments | OLO | 2026-03-18 | View |
| 510(k) | K252733 | ATLAS Expandable Osteotomy Wedge System | PLF | 2026-02-19 | View |
| 510(k) | K242516 | EUROPA Posterior Cervical Fusion System | NKG | 2024-11-19 | View |
| 510(k) | K241175 | MiRus MoRe Lumbar Plating System | KWQ | 2024-05-17 | View |
| 510(k) | K232348 | RIGEL 3DR Standalone Anterior Cervical Interbody Fusion System | OVE | 2023-10-27 | View |
| 510(k) | K232481 | RIGEL 3DR Anterior Cervical Corpectomy System | PLR | 2023-10-13 | View |
| 510(k) | K232154 | MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate Fixation | OVD | 2023-09-11 | View |
| 510(k) | K230369 | EUROPA Navigated Instruments | OLO | 2023-06-23 | View |
| 510(k) | K220441 | CYGNUS MoRe Anterior Cervical Plate System | KWQ | 2022-09-16 | View |
| 510(k) | K220115 | ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion System | OVD | 2022-05-13 | View |
| 510(k) | K210800 | IO Expandable Lumbar Interbody Fusion System | MAX | 2021-08-20 | View |
| 510(k) | K200685 | RIGEL 3DR Anterior Cervical Interbody Fusion System | ODP | 2020-06-11 | 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 ALIF | MAX | 2020-05-18 | View |
| 510(k) | K191867 | ATLAS Plating System | HRS | 2020-04-09 | View |
| 510(k) | K192268 | Europa Pedicle Screw System | NKB | 2019-10-22 | View |
| 510(k) | K191757 | EUROPA Pedicle Screw System | NKB | 2019-07-19 | View |
| 510(k) | K182524 | GALILEO Spine Alignment Monitoring System | OLO | 2019-06-17 | View |
| 510(k) | K190618 | RIGEL PEEK Anterior Cervical Interbody Fusion System | ODP | 2019-06-06 | View |
| 510(k) | K190666 | CYGNUS Anterior Cervical Plate System | KWQ | 2019-05-09 | View |
| 510(k) | K190415 | ATLAS Plating System | HRS | 2019-04-19 | View |
| 510(k) | K180337 | EUROPA Pedicle Screw System | NKB | 2019-03-14 | View |
| 510(k) | K182920 | MiRus Lumbar Interbody Fusion System consisting of CALLISTO PEEK Posterior Lumbar Interbody Fusion (PLIF); HYPERION PEEK Transforaminal Lumbar Interbody Fusion (TLIF); CALPYSO PEEK Lateral Lumbar Interbody Fusion (LLIF); ANTARES PEEK Anterior Lumbar Interbody Fusion (ALIF) | MAX | 2019-03-13 | View |
| 510(k) | K182970 | EUROPA Pedicle Screw System | NKB | 2019-01-22 | View |
| 510(k) | K182989 | AURORA Screw System | HWC | 2018-12-18 | View |
No matching devices.