Cleared Traditional

GALILEO Spine Alignment Monitoring System

K182524 · MiRus, LLC · Orthopedic

Jun 2019

Decision

277d

Days

Class 2

Risk

About This 510(k) Submission

K182524 is an FDA 510(k) clearance for the GALILEO Spine Alignment Monitoring System, a Orthopedic Stereotaxic Instrument (Class II — Special Controls, product code OLO), submitted by MiRus, LLC (Marietta, US). The FDA issued a Cleared decision on June 17, 2019, 277 days after receiving the submission on September 13, 2018. This device falls under the Orthopedic review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number	K182524 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 13, 2018
Decision Date	June 17, 2019
Days to Decision	277 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	OLO — Orthopedic Stereotaxic Instrument
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 882.4560
Definition	Stereotaxic Guidance During Orthopedic Surgery Procedures. Indicated For Orthopedic Joint Or Spine Surgery. Neurological Stereotaxic Instruments Are Classified Under Product Code Haw.