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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthopedic Augmented Reality
510(k) Number K242569
Device Name Mixed Reality Spine Navigation
Applicant
Brainlab AG
Olof-Palme-Str.9
Munich,  DE 81829
Applicant Contact Esther Moreno Garcia
Correspondent
Brainlab AG
Olof-Palme-Str.9
Munich,  DE 81829
Correspondent Contact Esther Moreno Garcia
Regulation Number882.4560
Classification Product Code
SBF  
Date Received08/28/2024
Decision Date 05/16/2025
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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