Mirus, LLC
Marietta, GA, US
MIRUS, LLC appears in FDA device records in Marietta, GA. FDA records list 24 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 24 510(k) clearances for Mirus, LLC between 2018 and 2026. The busiest year on record is 2019, with 9. The most recent is 2026, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2018 | 1 |
| 2019 | 9 |
| 2020 | 3 |
| 2021 | 1 |
| 2022 | 2 |
| 2023 | 4 |
| 2024 | 2 |
| 2026 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K253444 | EUROPA™ Posterior Cervical Fusion Navigated Instruments | OLO | Substantially Equivalent | |
| K252733 | ATLAS™ Expandable Osteotomy Wedge System | PLF | Substantially Equivalent | |
| K242516 | EUROPA™ Posterior Cervical Fusion System | NKG | Substantially Equivalent | |
| K241175 | MiRus MoRe Lumbar Plating System | KWQ | Substantially Equivalent | |
| K232348 | RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion System | OVE | Substantially Equivalent | |
| K232481 | RIGEL™ 3DR Anterior Cervical Corpectomy System | PLR | Substantially Equivalent | |
| K232154 | MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate Fixation | OVD | Substantially Equivalent | |
| K230369 | EUROPA™ Navigated Instruments | OLO | Substantially Equivalent | |
| K220441 | CYGNUS™ MoRe Anterior Cervical Plate System | KWQ | Substantially Equivalent | |
| K220115 | ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion System | OVD | Substantially Equivalent | |
| K210800 | IO Expandable Lumbar Interbody Fusion System | MAX | Substantially Equivalent | |
| K200685 | RIGEL 3DR Anterior Cervical Interbody Fusion System | ODP | Substantially Equivalent | |
| 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 | |
| K191867 | ATLAS Plating System | HRS | Substantially Equivalent | |
| K192268 | Europa Pedicle Screw System | NKB | Substantially Equivalent | |
| K191757 | EUROPA Pedicle Screw System | NKB | Substantially Equivalent | |
| K182524 | GALILEO Spine Alignment Monitoring System | OLO | Substantially Equivalent | |
| K190618 | RIGEL PEEK Anterior Cervical Interbody Fusion System | ODP | Substantially Equivalent | |
| K190666 | CYGNUS™ Anterior Cervical Plate System | KWQ | Substantially Equivalent | |
| K190415 | ATLAS Plating System | HRS | Substantially Equivalent | |
| K180337 | EUROPA Pedicle Screw System | NKB | Substantially Equivalent | |
| 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 | |
| K182970 | EUROPA™ Pedicle Screw System | NKB | Substantially Equivalent | |
| K182989 | AURORA™ Screw System | HWC | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3014655115 | 3014655115 | MIRUS, LLC | 1755 W Oak Parkway, Marietta, GA 30062 US | 2026 | and 5 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KWQAppliance, Fixation, Spinal Intervertebral Body
- PLFBone Wedge
- ODPIntervertebral Fusion Device With Bone Graft, Cervical
- MAXIntervertebral Fusion Device With Bone Graft, Lumbar
- OVEIntervertebral Fusion Device With Integrated Fixation, Cervical
- OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar
- OLOOrthopedic Stereotaxic Instrument
- MNIOrthosis, Spinal Pedicle Fixation
- MNHOrthosis, Spondylolisthesis Spinal Fixation
- HRSPlate, Fixation, Bone
- NKGPosterior Cervical Screw System
- HWCScrew, Fixation, Bone
- PLRSpinal Vertebral Body Replacement Device - Cervical
- IKKSystem, Isokinetic Testing And Evaluation
- NKBThoracolumbosacral Pedicle Screw System
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Mirus, LLC edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
Data as of , FDA export datePage updated Source: openFDA, public domain