Cleared Traditional

K232468 - SC Medica FFX (FDA 510(k) Clearance)

K232468 · Sc Medica · Orthopedic device

May 2024

Decision

268d

Days

Risk

K232468 is an FDA 510(k) clearance for the SC Medica FFX. This device is classified as a System, Facet Screw Spinal Device.

Submitted by Sc Medica (Strasbourg, FR). The FDA issued a Cleared decision on May 9, 2024, 268 days after receiving the submission on August 15, 2023.

This device falls under the Orthopedic FDA review panel.

Submission Details

510(k) Number	K232468 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 15, 2023
Decision Date	May 09, 2024
Days to Decision	268 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF