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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 K212245
Device Name Spine and Trauma Navigation System, Spine & Trauma 3D Navigation, Instrument Selection, Fluoro 3D, Registration Software Fluoro 3D, Registration Software Paired Point, Registration Software Spine Surface Matching, Spine Planning, Elements Screw Planning Spine, Elements Spine Screw Planning
Applicant
Brainlab AG
Olof-Palme-Str. 9
Munich,  DE 81829
Applicant Contact Chiara Cunico
Correspondent
Brainlab AG
Olof-Palme-Str. 9
Munich,  DE 81829
Correspondent Contact Chiara Cunico
Regulation Number882.4560
Classification Product Code
OLO  
Date Received07/19/2021
Decision Date 04/13/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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