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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthopedic Stereotaxic Instrument
510(k) Number K261665
Device Name CORUS™ Navigation System-GN
Applicant
Providence Medical Technology, Inc.
4234 Hacienda Dr.
Suite 150
Pleasanton,  CA  94588
Applicant Contact Edward Liou
Correspondent
ATS Colorado Springs
4628 Northpark Dr.
Colorado Springs,  CO  80918
Correspondent Contact Hannah Taggart
Regulation Number882.4560
Classification Product Code
OLO  
Date Received05/20/2026
Decision Date 06/18/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Orthopedic
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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