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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 K252841
Device Name REAL INTELLIGENCE™ CORI™ XT (CORI XT)
Applicant
Blue Belt Technologies, Inc.
2875 Railroad St.
Pittsburgh,  PA  15222
Applicant Contact Amy Zhi
Correspondent
Blue Belt Technologies, Inc.
2875 Railroad St.
Pittsburgh,  PA  15222
Correspondent Contact Amy Zhi
Regulation Number882.4560
Classification Product Code
OLO  
Subsequent Product Codes
HSX   JWH   KWS   MBH  
Date Received09/08/2025
Decision Date 12/05/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
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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