Cleared Traditional

FFX Facet Fixation System

K250679 · Sc Medica · Orthopedic

Dec 2025

Decision

273d

Days

—

Risk

About This 510(k) Submission

K250679 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 December 4, 2025, 273 days after receiving the submission on March 6, 2025. This device falls under the Orthopedic review panel.

Submission Details

510(k) Number	K250679 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 06, 2025
Decision Date	December 04, 2025
Days to Decision	273 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF