Cleared Special

K251885 - CAVUX Facet Fixation System (CAVUX FFS) and CORUS-LX Implant (FDA 510(k) Clearance)

Jul 2025
Decision
20d
Days
-
Risk

K251885 is an FDA 510(k) clearance for the CAVUX Facet Fixation System (CAVUX FFS) and CORUS-LX Implant. This device is classified as a System, Facet Screw Spinal Device.

Submitted by Providence Medical Technology, Inc. (Pleasanton, US). The FDA issued a Cleared decision on July 10, 2025, 20 days after receiving the submission on June 20, 2025.

This device falls under the Orthopedic FDA review panel.

Submission Details

510(k) Number K251885 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 2025
Decision Date July 10, 2025
Days to Decision 20 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code MRW - System, Facet Screw Spinal Device
Device Class -