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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 K253676
Device Name CORUS™ Posterior Cervical Stabilization System 3D (CORUS™ PCSS 3D)
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 Received11/21/2025
Decision Date 05/14/2026
Decision Substantially Equivalent (SESE)
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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