BRAINLAB KNEE ESSENTIAL, BRAINLAB KNEE UNLIMITED CI KNEE, CI KNEE UNLIMITED

Neurological Stereotaxic Instrument

BRAINLAB AG

The following data is part of a premarket notification filed by Brainlab Ag with the FDA for Brainlab Knee Essential, Brainlab Knee Unlimited Ci Knee, Ci Knee Unlimited.

Pre-market Notification Details

Device IDK073615
510k NumberK073615
Device Name:BRAINLAB KNEE ESSENTIAL, BRAINLAB KNEE UNLIMITED CI KNEE, CI KNEE UNLIMITED
ClassificationNeurological Stereotaxic Instrument
Applicant BRAINLAB AG KAPELLENSTRASSE 12 Feldkirchen,  DE 85622
ContactPer Persson
CorrespondentPer Persson
BRAINLAB AG KAPELLENSTRASSE 12 Feldkirchen,  DE 85622
Product CodeHAW  
CFR Regulation Number882.4560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-12-26
Decision Date2008-09-05
Summary:summary

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