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Sign in to claim this brandMIRUS LLC
US
Last updated May 23, 2026
What MIRUS LLC makes
Mirus LLC manufactures spinal fixation devices, including non-bioabsorbable pedicle screws for internal spinal stabilization, metallic interbody fusion cages, and internal fixation rod systems designed for minimally invasive procedures.
The company’s products are classified as Class II medical devices under FDA regulations and are authorised via 510(k) clearances and the FDA’s Unique Device Identification (UDI) system. These devices are listed in the FDA’s regulatory databases.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Mirus LLC manufacture?
Mirus LLC specializes in spinal fixation devices. Their primary products include non-bioabsorbable pedicle screws for spinal stabilization, metallic interbody fusion cages, and internal fixation rod systems designed for minimally invasive spinal procedures. These devices are engineered to support surgical interventions for spinal alignment and structural integrity.
Where is Mirus LLC based?
Mirus LLC is headquartered in the United States. The company’s location is relevant for regulatory oversight, as its devices are subject to FDA requirements and classifications applicable to US-based manufacturers.
How are Mirus LLC’s devices classified under FDA regulations?
Mirus LLC’s devices are classified as Class II medical devices under FDA regulations. This classification applies to products that pose moderate risk and require special controls to ensure safety and effectiveness, such as spinal fixation hardware. Class II devices typically require premarket notification (510(k)) clearance or other regulatory pathways to demonstrate compliance with FDA standards.
Which regulatory registries or databases list Mirus LLC’s devices?
Mirus LLC’s devices are listed in the FDA’s regulatory databases, specifically through 510(k) clearances and the FDA’s Unique Device Identification (UDI) system. These registries ensure transparency and traceability of authorised medical devices, allowing healthcare providers, regulators, and patients to access critical information about the devices’ safety, performance, and compliance status.
Why are Mirus LLC’s spinal devices authorised via the FDA’s UDI system?
The FDA’s Unique Device Identification (UDI) system assigns a unique product code to each device to improve tracking, reduce medical errors, and enhance post-market surveillance. Mirus LLC’s devices are authorised through UDI to ensure accurate identification in clinical settings, regulatory reporting, and public health monitoring, which helps maintain patient safety and device accountability throughout their lifecycle.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 080311078
Catalogue (312)
Page 6 of 7| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| EUROPA™ Pedicle Screw | 1-1-7545C | FDA UDI | Class II | Active |
| IO™ Expandable Lumbar Interbody System | 6-1030-L | FDA UDI | Class II | Active |
| EUROPA™ Pedicle Screw | 1-2-8570C | FDA UDI | Class II | Active |
| EUROPA™ Pedicle Screw | 1-1-6575C | FDA UDI | Class II | Active |
| EUROPA™ Pedicle Screw | 1-2-10585C | FDA UDI | Class II | Active |
| IO™ Expandable Lumbar Interbody System | 6-1222-L | FDA UDI | Class II | Active |
| EUROPA™ Pedicle Screw | 1-2-7580 | FDA UDI | Class II | Active |
| MIS MoRe™ Rod | 1-54-4545 | FDA UDI | Class II | Active |
| EUROPA™ Pedicle Screw | 1-1-10595C | FDA UDI | Class II | Active |
| EUROPA™ Pedicle Screw | 1-2-9540 | FDA UDI | Class II | Active |
| EUROPA™ Pedicle Screw | 1-2-105110 | FDA UDI | Class II | Active |
| EUROPA™ Pedicle Screw | 1-2-9545 | FDA UDI | Class II | Active |
| MIS MoRe™ Rod | 1-54-45110 | FDA UDI | Class II | Active |
| EUROPA™ Pedicle Screw | 1-2-10540 | FDA UDI | Class II | Active |
| EUROPA™ Pedicle Screw | 1-2-10555C | FDA UDI | Class II | Active |
| EUROPA™ Pedicle Screw | 1-1-5530C | FDA UDI | Class II | Active |
| EUROPA™ Pedicle Screw | 1-2-8575C | FDA UDI | Class II | Active |
| EUROPA™ Pedicle Screw | 1-2-105105 | FDA UDI | Class II | Active |
| MIS MoRe™ Rod | 1-54-4590 | FDA UDI | Class II | Active |
| EUROPA™ Pedicle Screw | 1-2-7565 | FDA UDI | Class II | Active |
| IO™ Expandable Lumbar Interbody System | 6-1230-L | FDA UDI | Class II | Active |
| EUROPA™ Pedicle Screw | 1-2-5540C | FDA UDI | Class II | Active |
| EUROPA™ Pedicle Screw | 1-2-9595C | FDA UDI | Class II | Active |
| EUROPA™ Pedicle Screw | 1-2-7540 | FDA UDI | Class II | Active |
| MIS MoRe™ Rod | 1-54-4555 | FDA UDI | Class II | Active |
| EUROPA™ Pedicle Screw | 1-2-9540C | FDA UDI | Class II | Active |
| EUROPA™ Pedicle Screw | 1-1-8550C | FDA UDI | Class II | Active |
| EUROPA™ Pedicle Screw | 1-2-95115C | FDA UDI | Class II | Active |
| EUROPA™ Pedicle Screw | 1-2-6565C | FDA UDI | Class II | Active |
| EUROPA™ Pedicle Screw | 1-1-10535C | FDA UDI | Class II | Active |
| EUROPA™ Pedicle Screw | 1-2-6580C | FDA UDI | Class II | Active |
| EUROPA™ Pedicle Screw | 1-2-8540C | FDA UDI | Class II | Active |
| EUROPA™ Pedicle Screw | 1-1-7575C | FDA UDI | Class II | Active |
| EUROPA™ Pedicle Screw | 1-2-10590C | FDA UDI | Class II | Active |
| EUROPA™ Pedicle Screw | 1-2-9580 | FDA UDI | Class II | Active |
| EUROPA™ Pedicle Screw | 1-1-8535C | FDA UDI | Class II | Active |
| EUROPA™ Pedicle Screw | 1-2-7580C | FDA UDI | Class II | Active |
| EUROPA™ Pedicle Screw | 1-2-9555 | FDA UDI | Class II | Active |
| RIGEL 3DR Anterior Cervical Interbody Fusion System | K200685 | FDA 510(k) | Class II | Active |
| AURORA™ Screw System | K182989 | FDA 510(k) | Class II | Active |
| MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate Fixation | K232154 | FDA 510(k) | Class II | Active |
| ATLAS Plating System | K191867 | FDA 510(k) | Class II | Active |
| CYGNUS™ Anterior Cervical Plate System | K190666 | FDA 510(k) | Class II | Active |
| EUROPA™ Navigated Instruments | K230369 | FDA 510(k) | Class II | Active |
| EUROPA Pedicle Screw System | K180337 | FDA 510(k) | Class II | Active |
| IO Expandable Lumbar Interbody Fusion System | K210800 | FDA 510(k) | Class II | Active |
| ATLAS™ Expandable Osteotomy Wedge System | K252733 | FDA 510(k) | Class II | Active |
| RIGEL PEEK Anterior Cervical Interbody Fusion System | K190618 | FDA 510(k) | Class II | Active |
| EUROPA Pedicle Screw System | K191757 | FDA 510(k) | Class II | Active |
| MiRus MoRe Lumbar Plating System | K241175 | FDA 510(k) | Class II | Active |
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