KOLIBRI SPINE

Neurological Stereotaxic Instrument

BRAINLAB AG

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

Pre-market Notification Details

Device IDK042721
510k NumberK042721
Device Name:KOLIBRI SPINE
ClassificationNeurological Stereotaxic Instrument
Applicant BRAINLAB AG AMMERTHALSTRASSE 8 Heimstetten,  DE 85551
ContactRainer Birkenbach
CorrespondentRainer Birkenbach
BRAINLAB AG AMMERTHALSTRASSE 8 Heimstetten,  DE 85551
Product CodeHAW  
CFR Regulation Number882.4560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-10-01
Decision Date2005-04-19
Summary:summary

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