Cleared Traditional

FFX Facet Fixation System

K252153 · Sc Medica · Orthopedic

Oct 2025

Decision

99d

Days

—

Risk

About This 510(k) Submission

K252153 is an FDA 510(k) clearance for the FFX Facet Fixation System, a System, Facet Screw Spinal Device, submitted by Sc Medica (Strasbourg, FR). The FDA issued a Cleared decision on October 16, 2025, 99 days after receiving the submission on July 9, 2025. This device falls under the Orthopedic review panel.

Submission Details

510(k) Number	K252153 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 09, 2025
Decision Date	October 16, 2025
Days to Decision	99 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF