Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

CORUS™ Navigation System-GN

K-Number: K261665 · 2026-06-18

ApplicantProvidence Medical Technology, Inc.
Decision Date2026-06-18
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

CORUS™ Navigation System-GN is the device name listed in this FDA 510(k) record. The listed applicant is Providence Medical Technology, Inc.. It received FDA 510(k) clearance on 2026-06-18 under 510(k) number K261665. 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-GN?

CORUS™ Navigation System-GN is a medical device that received FDA 510(k) clearance on 2026-06-18. The listed applicant is Providence Medical Technology, Inc.. The 510(k) number is K261665.

When did CORUS™ Navigation System-GN receive FDA 510(k) clearance?

CORUS™ Navigation System-GN received FDA 510(k) clearance on 2026-06-18, under 510(k) number K261665.

Who is the listed applicant for CORUS™ Navigation System-GN?

The FDA 510(k) record lists Providence Medical Technology, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07222787Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion OutcomesRECRUITINGNCT07721493Evaluation of the Safety and Effectiveness of the CORUS™ Posterior Cervical Stabilization System 3D (PCSS 3D) for the Treatment of 2-level Cervical Degenerative DiseaseNOT_YET_RECRUITING

Other records listing Providence Medical Technology, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253676CORUS™ Posterior Cervical Stabilization System 3D (CORUS™ PCSS 3D)K253190CORUS-LX ImplantK251060CORUS™ Navigation System-GXK251885CAVUX Facet Fixation System (CAVUX FFS) and CORUS-LX ImplantK241035PMT Posterior Cervical Stabilization System (PCSS)K240625CORUS Navigation Access System

View all 19 devices →

Related Devices (Code: OLO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261410Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration Kit))Suite 201, National Innovation CentreK261205SPINEART Navigation Instrument SystemSpineart SAK262121Ion-L Navigated InstrumentsSurGenTec, LLCK261024TMINI Miniature Robotic SystemTHINK Surgical, Inc.K261113Op.n™ Spine Navigation and Robotic GuidanceEcential RoboticsK261852OTS HipOrtoma AB

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.

↑