Data / Medical devices / United States / Mirus, LLC
Mirus, LLC: FDA-registered device maker in Marietta, GA, United States, 21 510(k) clearances
Mirus, LLC is registered with the FDA (registration 3014655115) in Marietta, GA, United States. It lists 15 device types. The FDA files 21 510(k) clearances under its listings, the newest dated March 18, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014655115
- Address
- 1755 W Oak Parkway Suite 100, Marietta, GA, United States, 30062
- Owner or operator
- MiRus, LLC (10059692)
- Roles
- Manufacturer
- First device listed
- February 12, 2019
- Registered through
- 2026
- Brand names listed
- ANTARES 3DR ALIF, ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion System, ANTARES PEEK ALIF, ATLAS MoRe Plating System, CALLISTO 3DR PLIF, CALLISTO PEEK PLIF, CALYPSO 3DR LLIF, CALYPSO PEEK LLIF and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 18, 2026 | K253444 | EUROPA Posterior Cervical Fusion Navigated Instruments | OLO | Substantially Equivalent | MiRus, LLC | accessdata.fda.gov |
| February 19, 2026 | K252733 | ATLAS Expandable Osteotomy Wedge System | PLF | Substantially Equivalent | MiRus, LLC | accessdata.fda.gov |
| November 19, 2024 | K242516 | EUROPA Posterior Cervical Fusion System | NKG | Substantially Equivalent | MiRus, LLC | accessdata.fda.gov |
| May 17, 2024 | K241175 | MiRus MoRe Lumbar Plating System | KWQ | Substantially Equivalent | MiRus, LLC | accessdata.fda.gov |
| October 27, 2023 | K232348 | RIGEL 3DR Standalone Anterior Cervical Interbody Fusion System | OVE | Substantially Equivalent | MiRus, LLC | accessdata.fda.gov |
| October 13, 2023 | K232481 | RIGEL 3DR Anterior Cervical Corpectomy System | PLR | Substantially Equivalent | MiRus, LLC | accessdata.fda.gov |
| September 11, 2023 | K232154 | MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate Fixation | OVD | Substantially Equivalent | MiRus, LLC | accessdata.fda.gov |
| June 23, 2023 | K230369 | EUROPA Navigated Instruments | OLO | Substantially Equivalent | MiRus, LLC | accessdata.fda.gov |
| September 16, 2022 | K220441 | CYGNUS MoRe Anterior Cervical Plate System | KWQ | Substantially Equivalent | MiRus, LLC | accessdata.fda.gov |
| May 13, 2022 | K220115 | ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion System | OVD | Substantially Equivalent | MiRus, LLC | accessdata.fda.gov |
| August 20, 2021 | K210800 | IO Expandable Lumbar Interbody Fusion System | MAX | Substantially Equivalent | MiRus, LLC | accessdata.fda.gov |
| June 11, 2020 | K200685 | RIGEL 3DR Anterior Cervical Interbody Fusion System | ODP | Substantially Equivalent | MiRus, LLC | accessdata.fda.gov |
| May 18, 2020 | 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 | Substantially Equivalent | MiRus, LLC | accessdata.fda.gov |
| April 9, 2020 | K191867 | ATLAS Plating System | HRS | Substantially Equivalent | MiRus, LLC | accessdata.fda.gov |
| October 22, 2019 | K192268 | Europa Pedicle Screw System | NKB | Substantially Equivalent | MiRus, LLC | accessdata.fda.gov |
| July 19, 2019 | K191757 | EUROPA Pedicle Screw System | NKB | Substantially Equivalent | MiRus, LLC | accessdata.fda.gov |
| June 6, 2019 | K190618 | RIGEL PEEK Anterior Cervical Interbody Fusion System | ODP | Substantially Equivalent | MiRus, LLC | accessdata.fda.gov |
| May 9, 2019 | K190666 | CYGNUS Anterior Cervical Plate System | KWQ | Substantially Equivalent | MiRus, LLC | accessdata.fda.gov |
| March 14, 2019 | K180337 | EUROPA Pedicle Screw System | NKB | Substantially Equivalent | MiRus, LLC | accessdata.fda.gov |
| March 13, 2019 | 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 | Substantially Equivalent | MiRus, LLC | accessdata.fda.gov |
| January 22, 2019 | K182970 | EUROPA Pedicle Screw System | NKB | Substantially Equivalent | MiRus, LLC | accessdata.fda.gov |
Compare with other makers
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- All makers of Plate, Fixation, Bone
Updated March 18, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.