CIRQ Robotic Alignment Module, Cirq, Cirq Robotic Alignment Module Spinal, Cirq Robotic Alignment Cranial And Spine, CIRQ Robotic Alignment Cranial And Spine System

Orthopedic Stereotaxic Instrument

Brainlab AG

The following data is part of a premarket notification filed by Brainlab Ag with the FDA for Cirq Robotic Alignment Module, Cirq, Cirq Robotic Alignment Module Spinal, Cirq Robotic Alignment Cranial And Spine, Cirq Robotic Alignment Cranial And Spine System.

Pre-market Notification Details

Device IDK202320
510k NumberK202320
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
ClassificationOrthopedic Stereotaxic Instrument
Applicant Brainlab AG Olof-Palme-Str. 9 Munich,  DE 80809
ContactCunico Chiara
CorrespondentCunico Chiara
Brainlab AG Olof-Palme-Str. 9 Munich,  DE 80809
Product CodeOLO  
CFR Regulation Number882.4560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-08-17
Decision Date2020-12-23

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04056481141646 K202320 000
04056481141646 K202320 000
04056481141646 K202320 000
04056481141646 K202320 000
04056481141646 K202320 000
04056481141646 K202320 000
04056481141646 K202320 000
04056481141646 K202320 000
04056481141646 K202320 000
04056481141646 K202320 000
04056481141646 K202320 000
04056481141646 K202320 000
04056481141646 K202320 000
04056481141646 K202320 000
04056481141646 K202320 000

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