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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 K260601
Device Name REAL INTELLIGENCE™ CORI™
Applicant
Blue Belt Technologies, Inc.
2875 Railroad St.
Pittsburgh,  PA  15222
Applicant Contact Samantha Zanetti
Correspondent
Blue Belt Technologies, Inc.
2875 Railroad St.
Pittsburgh,  PA  15222
Correspondent Contact Samantha Zanetti
Regulation Number882.4560
Classification Product Code
OLO  
Date Received02/24/2026
Decision Date 03/26/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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