Cleared Traditional

K250679 - FFX Facet Fixation System (FDA 510(k) Clearance)

K250679 · Sc Medica · Orthopedic device

Dec 2025

Decision

273d

Days

Risk

K250679 is an FDA 510(k) clearance for the FFX Facet Fixation System. This device is classified as 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 FDA review panel.

Submission Details

510(k) Number	K250679 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (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