Cirq Arm System (2.0);Alignment System Spine

Orthopedic Stereotaxic Instrument

Brainlab AG

The following data is part of a premarket notification filed by Brainlab Ag with the FDA for Cirq Arm System (2.0);alignment System Spine.

Pre-market Notification Details

Device IDK222966
510k NumberK222966
Device Name:Cirq Arm System (2.0);Alignment System Spine
ClassificationOrthopedic Stereotaxic Instrument
Applicant Brainlab AG Olof-Palme-Str. 9 Munich,  DE 81829
ContactSadwini Suresh
CorrespondentSadwini Suresh
Brainlab AG Olof-Palme-Str. 9 Munich,  DE 81829
Product CodeOLO  
CFR Regulation Number882.4560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-09-27
Decision Date2022-10-27

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04056481143961 K222966 000

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