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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 K202320
Device Name CIRQ Robotic Alignment Module, Cirq, Cirq Robotic Alignment Module Spinal, Cirq Robotic Alignment Cranial and Spine, CIRQ Robotic Alignment Cranial and Spine System
Brainlab AG
Olof-Palme-Str. 9
Munich,  DE 80809
Applicant Contact Cunico Chiara
Brainlab AG
Olof-Palme-Str. 9
Munich,  DE 80809
Correspondent Contact Cunico Chiara
Regulation Number882.4560
Classification Product Code
Date Received08/17/2020
Decision Date 12/23/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No