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FDA 510(k)

FFX Facet Fixation System

K-Number: K252153 · 2025-10-16

ApplicantSc Medica
Decision Date2025-10-16
Product CodeMRW
DecisionSubstantially Equivalent

Device Summary

FFX Facet Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Sc Medica. It received FDA 510(k) clearance on 2025-10-16 under 510(k) number K252153. The device is classified under product code MRW. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FFX Facet Fixation System?

FFX Facet Fixation System is a medical device that received FDA 510(k) clearance on 2025-10-16. The listed applicant is Sc Medica. The 510(k) number is K252153.

When did FFX Facet Fixation System receive FDA 510(k) clearance?

FFX Facet Fixation System received FDA 510(k) clearance on 2025-10-16, under 510(k) number K252153.

Who is the listed applicant for FFX Facet Fixation System?

The FDA 510(k) record lists Sc Medica as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FFX Facet Fixation System?

The FDA product code for FFX Facet Fixation System is MRW.

Other records listing Sc Medica 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.

K250679FFX Facet Fixation SystemK232468SC Medica FFX

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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