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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 K222966
Device Name Cirq Arm System (2.0);Alignment System Spine
Applicant
Brainlab AG
Olof-Palme-Str. 9
Munich,  DE 81829
Applicant Contact Sadwini Suresh
Correspondent
Brainlab AG
Olof-Palme-Str. 9
Munich,  DE 81829
Correspondent Contact Sadwini Suresh
Regulation Number882.4560
Classification Product Code
OLO  
Date Received09/27/2022
Decision Date 10/27/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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