Automatic Registration

Orthopedic Stereotaxic Instrument

Brainlab AG

The following data is part of a premarket notification filed by Brainlab Ag with the FDA for Automatic Registration.

Pre-market Notification Details

Device IDK203679
510k NumberK203679
Device Name:Automatic Registration
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)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-12-17
Decision Date2021-03-18

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