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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 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 2025-07-30 under 510(k) 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. The listed applicant is Providence Medical Technology, Inc.. The 510(k) number is K251060.

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

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

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

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-GX?

The FDA product code for CORUS™ Navigation System-GX 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.

K261665CORUS™ Navigation System-GNK253676CORUS™ Posterior Cervical Stabilization System 3D (CORUS™ PCSS 3D)K253190CORUS-LX ImplantK251885CAVUX 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.

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