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FDA 510(k)

GALILEO Spine Alignment Monitoring System

K-Number: K182524 · 2019-06-17

ApplicantMiRus, LLC
Decision Date2019-06-17
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

GALILEO Spine Alignment Monitoring System is a medical device manufactured by MiRus, LLC. It received FDA 510(k) clearance on 2019-06-17 under approval number K182524. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GALILEO Spine Alignment Monitoring System?

GALILEO Spine Alignment Monitoring System is a medical device that received FDA 510(k) clearance on 2019-06-17. It is manufactured by MiRus, LLC. The 510(k) number is K182524.

When was GALILEO Spine Alignment Monitoring System approved by the FDA?

GALILEO Spine Alignment Monitoring System received FDA 510(k) clearance on 2019-06-17, under approval number K182524.

What company makes GALILEO Spine Alignment Monitoring System?

GALILEO Spine Alignment Monitoring System is manufactured by MiRus, LLC.

What is the FDA product code for GALILEO Spine Alignment Monitoring System?

The FDA product code for GALILEO Spine Alignment Monitoring System is OLO.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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