FDA 510(k)

CORUS Navigation System-GX

K-Number: K251060 · 2025-07-30

ApplicantProvidence Medical Technology, Inc.

Decision Date2025-07-30

Product CodeOLO

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

CORUS Navigation System-GX is a medical device manufactured by Providence Medical Technology, Inc.. It received FDA 510(k) clearance on 2025-07-30 under approval number K251060. 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 CORUS Navigation System-GX?

CORUS Navigation System-GX is a medical device that received FDA 510(k) clearance on 2025-07-30. It is manufactured by Providence Medical Technology, Inc.. The 510(k) number is K251060.

When was CORUS Navigation System-GX approved by the FDA?

CORUS Navigation System-GX received FDA 510(k) clearance on 2025-07-30, under approval number K251060.

What company makes CORUS Navigation System-GX?

CORUS Navigation System-GX is manufactured by Providence Medical Technology, Inc..

What is the FDA product code for CORUS Navigation System-GX?

The FDA product code for CORUS Navigation System-GX is OLO.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT07616050 Evaluation of the Impact of Virtual Park on Training Motivation in Adult Patients NOT_YET_RECRUITING NCT07173309 Evaluation of Eye Gaze Sharing in the Operating Room RECRUITING NCT07174479 Eye Gaze Guidance Evaluation in Phantoms COMPLETED NCT06631638 EMPHASYS Cup Positioning in THA With Non-Invasive Navigation (Velys Hip Navigation (VHN)) RECRUITING NCT07271238 Feasibility Study on the VERAFEYE Imaging and Navigation System for Guided Catheter Ablation Procedures RECRUITING

Related PubMed Literature

PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025)

Other Devices by Providence Medical Technology, Inc.

K161642CAVUX Cervical Cage K172279PMT Posterior Fixation System K170698ALLY(TM) Bone Screws K163474CAVUX CervicalCage-L SA System K163374ALLY Facet Screws K180876DTRAX Spinal System

View all 18 devices →

Related Devices (Code: OLO)

K162375Envision 3D: Image Guidance System7D Surgical, Inc. K162341Stryker OrthoMap Precision Knee systemStryker Leibinger GmbH & Co KG K162195TSolution One Cup1 Surgical SystemTHINK Surgical, Inc. K160385Precision ScrewCryptych Pty, Ltd. K153700Aesculap(R) Implant Systems (AIS) S4 Navigation InstrumentsAesculap Implant Systems, LLC K153240Styrker OrthoMap Express Knee SystemStryker Corporate

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.