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FDA 510(k)

CORUS™ Posterior Cervical Stabilization System 3D (CORUS™ PCSS 3D)

K-Number: K253676 · 2026-05-14

ApplicantProvidence Medical Technology, Inc.
Decision Date2026-05-14
Product CodeMRW
DecisionSubstantially Equivalent

Device Summary

CORUS™ Posterior Cervical Stabilization System 3D (CORUS™ PCSS 3D) 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 2026-05-14 under 510(k) number K253676. The device is classified under product code MRW. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CORUS™ Posterior Cervical Stabilization System 3D (CORUS™ PCSS 3D)?

CORUS™ Posterior Cervical Stabilization System 3D (CORUS™ PCSS 3D) is a medical device that received FDA 510(k) clearance on 2026-05-14. The listed applicant is Providence Medical Technology, Inc.. The 510(k) number is K253676.

When did CORUS™ Posterior Cervical Stabilization System 3D (CORUS™ PCSS 3D) receive FDA 510(k) clearance?

CORUS™ Posterior Cervical Stabilization System 3D (CORUS™ PCSS 3D) received FDA 510(k) clearance on 2026-05-14, under 510(k) number K253676.

Who is the listed applicant for CORUS™ Posterior Cervical Stabilization System 3D (CORUS™ PCSS 3D)?

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™ Posterior Cervical Stabilization System 3D (CORUS™ PCSS 3D)?

The FDA product code for CORUS™ Posterior Cervical Stabilization System 3D (CORUS™ PCSS 3D) is MRW.

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.

NCT07721493Evaluation 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_RECRUITINGNCT07222787Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion OutcomesRECRUITING

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-GNK253190CORUS-LX ImplantK251060CORUS™ Navigation System-GXK251885CAVUX Facet Fixation System (CAVUX FFS) and CORUS-LX ImplantK241035PMT Posterior Cervical Stabilization System (PCSS)K240625CORUS Navigation Access System

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Related Devices (Code: MRW)

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.

K261209Ion-LSurGenTec, LLCK253432DiversiVy™ Facet Screw SystemVy Spine, LLCK251714Ion-CSurGenTec, LLCK250679FFX Facet Fixation SystemSc MedicaK253190CORUS-LX ImplantProvidence Medical Technology, Inc.K252153FFX Facet Fixation SystemSc Medica

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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