Cleared Traditional

K253190 - CORUS-LX Implant (FDA 510(k) Clearance)

K253190 · Providence Medical Technology, Inc. · Orthopedic device

Nov 2025

Decision

55d

Days

Risk

K253190 is an FDA 510(k) clearance for the 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 November 20, 2025, 55 days after receiving the submission on September 26, 2025.

This device falls under the Orthopedic FDA review panel.

Submission Details

510(k) Number	K253190 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 26, 2025
Decision Date	November 20, 2025
Days to Decision	55 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF