Spine & Trauma Navigation, Spine Navigation, Navigation Software Spine & Trauma, Alignment System Spine, Alignment Software Spine, Cirq Arm System

Orthopedic Stereotaxic Instrument

Brainlab AG

The following data is part of a premarket notification filed by Brainlab Ag with the FDA for Spine & Trauma Navigation, Spine Navigation, Navigation Software Spine & Trauma, Alignment System Spine, Alignment Software Spine, Cirq Arm System.

Pre-market Notification Details

Device IDK221618
510k NumberK221618
Device Name:Spine & Trauma Navigation, Spine Navigation, Navigation Software Spine & Trauma, Alignment System Spine, Alignment Software Spine, Cirq Arm System
ClassificationOrthopedic Stereotaxic Instrument
Applicant Brainlab AG Olof-Palme-Str.9 Munich,  DE 81829
ContactChiara Cunico
CorrespondentChiara Cunico
Brainlab AG Olof-Palme-Str.9 Munich,  DE 81829
Product CodeOLO  
CFR Regulation Number882.4560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-06-03
Decision Date2022-08-30

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04056481144470 K221618 000
04056481145866 K221618 000
04056481145859 K221618 000
04056481145842 K221618 000

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