Cleared Traditional

EUROPA? Navigated Instruments

K230369 · MiRus, LLC · Orthopedic

Jun 2023

Decision

133d

Days

Class 2

Risk

About This 510(k) Submission

K230369 is an FDA 510(k) clearance for the EUROPA? Navigated Instruments, 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 23, 2023, 133 days after receiving the submission on February 10, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number	K230369 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 10, 2023
Decision Date	June 23, 2023
Days to Decision	133 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.