MiRus, LLC
Medical device manufacturer in Marietta, GA.
24510(k) clearances
0PMA approvals
0recalls
Device types
- NKB Thoracolumbosacral Pedicle Screw System 4
- MAX Intervertebral Fusion Device With Bone… 3
- KWQ Appliance, Fixation, Spinal Intervertebral… 3
- OLO Orthopedic Stereotaxic Instrument 3
- HRS Plate, Fixation, Bone 2
- ODP Intervertebral Fusion Device With Bone… 2
- OVD Intervertebral Fusion Device With… 2
- HWC Screw, Fixation, Bone 1
- PLR Spinal Vertebral Body Replacement Device -… 1
- OVE Intervertebral Fusion Device With… 1
- NKG Posterior Cervical Screw System 1
- PLF Bone Wedge 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K253444 | EUROPA Posterior Cervical Fusion Navigated InstrumentsOLO · Traditional | 03/18/2026SE |
| K252733 | ATLAS Expandable Osteotomy Wedge SystemPLF · Traditional | 02/19/2026SE |
| K242516 | EUROPA Posterior Cervical Fusion SystemNKG · Traditional | 11/19/2024SE |
| K241175 | MiRus MoRe Lumbar Plating SystemKWQ · Traditional | 05/17/2024SE |
| K232348 | RIGEL 3DR Standalone Anterior Cervical Interbody Fusion SystemOVE · Traditional | 10/27/2023SE |
| K232481 | RIGEL 3DR Anterior Cervical Corpectomy SystemPLR · Traditional | 10/13/2023SE |
| K232154 | MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate FixationOVD · Traditional | 09/11/2023SE |
| K230369 | EUROPA Navigated InstrumentsOLO · Traditional | 06/23/2023SE |
| K220441 | CYGNUS MoRe Anterior Cervical Plate SystemKWQ · Traditional | 09/16/2022SE |
| K220115 | ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion SystemOVD · Traditional | 05/13/2022SE |
| K210800 | IO Expandable Lumbar Interbody Fusion SystemMAX · Traditional | 08/20/2021SE |
| K200685 | RIGEL 3DR Anterior Cervical Interbody Fusion SystemODP · Traditional | 06/11/2020SE |
| K191906 | MiRus 3D Printed Lumbar Interbody Fusion Systems consisting of the Callisto 3D Printed…MAX · Traditional | 05/18/2020SE |
| K191867 | ATLAS Plating SystemHRS · Traditional | 04/09/2020SE |
| K192268 | Europa Pedicle Screw SystemNKB · Traditional | 10/22/2019SE |
| K191757 | EUROPA Pedicle Screw SystemNKB · Special | 07/19/2019SE |
| K182524 | GALILEO Spine Alignment Monitoring SystemOLO · Traditional | 06/17/2019SE |
| K190618 | RIGEL PEEK Anterior Cervical Interbody Fusion SystemODP · Traditional | 06/06/2019SE |
| K190666 | CYGNUS Anterior Cervical Plate SystemKWQ · Traditional | 05/09/2019SE |
| K190415 | ATLAS Plating SystemHRS · Traditional | 04/19/2019SE |
| K180337 | EUROPA Pedicle Screw SystemNKB · Traditional | 03/14/2019SE |
| K182920 | MiRus Lumbar Interbody Fusion System consisting of CALLISTO PEEK Posterior Lumbar…MAX · Traditional | 03/13/2019SE |
| K182970 | EUROPA Pedicle Screw SystemNKB · Traditional | 01/22/2019SE |
| K182989 | AURORA Screw SystemHWC · Traditional | 12/18/2018SE |