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FDA 510(k)

PMT Posterior Cervical Stabilization System (PCSS)

K-Number: K241035 · 2024-06-25

ApplicantProvidence Medical Technology, Inc.
Decision Date2024-06-25
Product CodeMRW
DecisionSubstantially Equivalent

Device Summary

PMT Posterior Cervical Stabilization System (PCSS) 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 2024-06-25 under 510(k) number K241035. The device is classified under product code MRW. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PMT Posterior Cervical Stabilization System (PCSS)?

PMT Posterior Cervical Stabilization System (PCSS) is a medical device that received FDA 510(k) clearance on 2024-06-25. The listed applicant is Providence Medical Technology, Inc.. The 510(k) number is K241035.

When did PMT Posterior Cervical Stabilization System (PCSS) receive FDA 510(k) clearance?

PMT Posterior Cervical Stabilization System (PCSS) received FDA 510(k) clearance on 2024-06-25, under 510(k) number K241035.

Who is the listed applicant for PMT Posterior Cervical Stabilization System (PCSS)?

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 PMT Posterior Cervical Stabilization System (PCSS)?

The FDA product code for PMT Posterior Cervical Stabilization System (PCSS) 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-GNK253676CORUS™ Posterior Cervical Stabilization System 3D (CORUS™ PCSS 3D)K253190CORUS-LX ImplantK251060CORUS™ Navigation System-GXK251885CAVUX Facet Fixation System (CAVUX FFS) and CORUS-LX ImplantK240625CORUS Navigation Access System

View all 19 devices →

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, LLCK253676CORUS™ Posterior Cervical Stabilization System 3D (CORUS™ PCSS 3D)Providence Medical Technology, Inc.K253432DiversiVy™ Facet Screw SystemVy Spine, LLCK251714Ion-CSurGenTec, LLCK250679FFX Facet Fixation SystemSc MedicaK253190CORUS-LX ImplantProvidence Medical Technology, Inc.

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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