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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 K231963
Device Name REAL INTELLIGENCE™ CORI™
Applicant
Blue Belt Technologies, Inc.
2875 Railroad St.
Pittsburgh,  PA  15222
Applicant Contact Corrine Herlinger
Correspondent
Blue Belt Technologies, Inc.
2875 Railroad St.
Pittsburgh,  PA  15222
Correspondent Contact Corrine Herlinger
Regulation Number882.4560
Classification Product Code
OLO  
Subsequent Product Codes
HSX   JWH   MBH   NJD  
Date Received07/03/2023
Decision Date 08/01/2023
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
Recalls CDRH Recalls
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