Galileo Spine Alignment Monitoring System
FDA 510(k)Class II (US FDA 510(k))
by Mirus Llc
Identifiers
- 510(k) Number
- K182524 FDA 510(k)
- FDA Product Code
- OLO FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.4560 FDA 510(k)
- Regulation Number
- 882.4560 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Galileo Spine Alignment Monitoring System is a stereotaxic instrument intended to provide intra-operative measurements to a surgeon to aid in the selection and positioning of orthopaedic implant system components relative to anatomical structures and reference axes. It is a wireless, real-time measurement and monitoring system of segmental and global sagittal spine alignment.
The device is supplied by MiRus, LLC and was cleared through the FDA 510(k) process under K182524. It is classified as a Class II medical device with product code OLO and regulation number 21 CFR 882.4560. The system is used in operative settings to support spinal alignment assessment during surgery.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: GALILEO™ Spine Alignment Monitoring System - MiRus, GALILEO™ Spine Alignment Monitoring System Receives FDA 510 ... - MiRus, GALILEO Spine Alignment Monitoring System (K182524) — FDA 510(k ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K182524 | Class II | Active |
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Manufacturer
- Manufacturer
- Mirus Llc
- FDA Applicant
- MiRus, LLC
Sources (1)
- FDA 510(k) K182524 24 fields · synced Sep 26, 2026