Company · US
MiRus, LLC
FDA 510(k) clearances and medical device recalls filed under this name, 2018 to 2026. Name variants (Inc, Corp, punctuation) are merged.
24510(k) clearances (2 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| NKB | Thoracolumbosacral Pedicle Screw System | 4 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 3 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 3 |
| OLO | Orthopedic Stereotaxic Instrument | 3 |
| HRS | Plate, Fixation, Bone | 2 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 2 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | 2 |
| HWC | Screw, Fixation, Bone | 1 |
| NKG | Posterior Cervical Screw System | 1 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | 1 |
| PLF | Bone Wedge | 1 |
| PLR | Spinal Vertebral Body Replacement Device - Cervical | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 18, 2026 | K253444 | EUROPA Posterior Cervical Fusion Navigated Instruments MiRus, LLC | OLO |
| Feb 19, 2026 | K252733 | ATLAS Expandable Osteotomy Wedge System MiRus, LLC | PLF |
| Nov 19, 2024 | K242516 | EUROPA Posterior Cervical Fusion System MiRus, LLC | NKG |
| May 17, 2024 | K241175 | MiRus MoRe Lumbar Plating System MiRus, LLC | KWQ |
| Oct 27, 2023 | K232348 | RIGEL 3DR Standalone Anterior Cervical Interbody Fusion System MiRus, LLC | OVE |
| Oct 13, 2023 | K232481 | RIGEL 3DR Anterior Cervical Corpectomy System MiRus, LLC | PLR |
| Sep 11, 2023 | K232154 | MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate Fixation MiRus, LLC | OVD |
| Jun 23, 2023 | K230369 | EUROPA Navigated Instruments MiRus, LLC | OLO |
| Sep 16, 2022 | K220441 | CYGNUS MoRe Anterior Cervical Plate System MiRus, LLC | KWQ |
| May 13, 2022 | K220115 | ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion System MiRus, LLC | OVD |
| Aug 20, 2021 | K210800 | IO Expandable Lumbar Interbody Fusion System MiRus, LLC | MAX |
| Jun 11, 2020 | K200685 | RIGEL 3DR Anterior Cervical Interbody Fusion System MiRus, LLC | ODP |
| May 18, 2020 | K191906 | MiRus 3D Printed Lumbar Interbody Fusion Systems consisting of the Callisto 3D Printed PLIF, HYPERION 3D Printed TLIF, C MiRus, LLC | MAX |
| Apr 9, 2020 | K191867 | ATLAS Plating System MiRus, LLC | HRS |
| Oct 22, 2019 | K192268 | Europa Pedicle Screw System MiRus, LLC | NKB |
| Jul 19, 2019 | K191757 | EUROPA Pedicle Screw System MiRus, LLC | NKB |
| Jun 17, 2019 | K182524 | GALILEO Spine Alignment Monitoring System MiRus, LLC | OLO |
| Jun 6, 2019 | K190618 | RIGEL PEEK Anterior Cervical Interbody Fusion System MiRus, LLC | ODP |
| May 9, 2019 | K190666 | CYGNUS Anterior Cervical Plate System MiRus, LLC | KWQ |
| Apr 19, 2019 | K190415 | ATLAS Plating System MiRus, LLC | HRS |
| Mar 14, 2019 | K180337 | EUROPA Pedicle Screw System MiRus, LLC | NKB |
| Mar 13, 2019 | K182920 | MiRus Lumbar Interbody Fusion System consisting of CALLISTO PEEK Posterior Lumbar Interbody Fusion (PLIF); HYPERION P MiRus, LLC | MAX |
| Jan 22, 2019 | K182970 | EUROPA Pedicle Screw System MiRus, LLC | NKB |
| Dec 18, 2018 | K182989 | AURORA Screw System MiRus, LLC | HWC |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||