Cleared Traditional

CORUS? Navigation System-GX

K251060 · Providence Medical Technology, Inc. · Orthopedic

Jul 2025

Decision

117d

Days

Class 2

Risk

About This 510(k) Submission

K251060 is an FDA 510(k) clearance for the CORUS? Navigation System-GX, a Orthopedic Stereotaxic Instrument (Class II — Special Controls, product code OLO), submitted by Providence Medical Technology, Inc. (Pleasanton, US). The FDA issued a Cleared decision on July 30, 2025, 117 days after receiving the submission on April 4, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number	K251060 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 04, 2025
Decision Date	July 30, 2025
Days to Decision	117 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.