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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 K183605
Device Name Spine & Trauma Navigation
Applicant
Brainlab AG
Olof-Palme-Str 9
Munich,  DE 81829
Applicant Contact Alexander Schweirsch
Correspondent
Brainlab AG
Olof-Palme-Str 9
Munich,  DE 81829
Correspondent Contact Hugo Morales
Regulation Number882.4560
Classification Product Code
OLO  
Date Received12/26/2018
Decision Date 08/29/2019
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
Recalls CDRH Recalls
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