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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Facet Screw Spinal Device
510(k) Number K253190
Device Name CORUS-LX Implant
Applicant
Providence Medical Technology, Inc.
4234 Hacienda Dr.
Suite 150
Pleasanton,  CA  94588
Applicant Contact Edward Liou
Correspondent
R. Dubois Consulting, LLC
584 Rio Del Mar Blvd.
Aptos,  CA  95003
Correspondent Contact Roxanne Dubois
Classification Product Code
MRW  
Date Received09/26/2025
Decision Date 11/20/2025
Decision Substantially Equivalent (SESE)
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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