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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 K221618
Device Name Spine & Trauma Navigation, Spine Navigation, Navigation Software Spine & Trauma, Alignment System Spine, Alignment Software Spine, Cirq Arm System
Brainlab AG
Munich,  DE 81829
Applicant Contact Chiara Cunico
Brainlab AG
Munich,  DE 81829
Correspondent Contact Chiara Cunico
Regulation Number882.4560
Classification Product Code
Date Received06/03/2022
Decision Date 08/30/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No