Cleared Traditional

CORUS-LX Implant

K253190 · Providence Medical Technology, Inc. · Orthopedic
Nov 2025
Decision
55d
Days
—
Risk

About This 510(k) Submission

K253190 is an FDA 510(k) clearance for the CORUS-LX Implant, 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 review panel.

Submission Details

510(k) Number K253190 FDA.gov
FDA Decision Cleared 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

Device Classification

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