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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Neurological Stereotaxic Instrument
510(k) Number K253663
Device Name Zeta Navigation System
Applicant
Zeta Surgical, Inc.
280 Summer St.
Floor 7
Boston,  MA  02210
Applicant Contact Hieu Le Mau
Correspondent
Zeta Surgical, Inc.
280 Summer St.
Floor 7
Boston,  MA  02210
Correspondent Contact Hieu Le Mau
Regulation Number882.4560
Classification Product Code
HAW  
Date Received11/20/2025
Decision Date 05/01/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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