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FDA 510(k)

SC Medica FFX

K-Number: K232468 · 2024-05-09

ApplicantSc Medica
Decision Date2024-05-09
Product CodeMRW
DecisionSubstantially Equivalent

Device Summary

SC Medica FFX is the device name listed in this FDA 510(k) record. The listed applicant is Sc Medica. It received FDA 510(k) clearance on 2024-05-09 under 510(k) number K232468. The device is classified under product code MRW. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SC Medica FFX?

SC Medica FFX is a medical device that received FDA 510(k) clearance on 2024-05-09. The listed applicant is Sc Medica. The 510(k) number is K232468.

When did SC Medica FFX receive FDA 510(k) clearance?

SC Medica FFX received FDA 510(k) clearance on 2024-05-09, under 510(k) number K232468.

Who is the listed applicant for SC Medica FFX?

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 SC Medica FFX?

The FDA product code for SC Medica FFX 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 SystemK252153FFX Facet Fixation System

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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