CI KNEE, CI MI TKR

Neurological Stereotaxic Instrument

BRAINLAB, AG

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

Pre-market Notification Details

Device IDK052966
510k NumberK052966
Device Name:CI KNEE, CI MI TKR
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 Received2005-10-21
Decision Date2006-02-13
Summary:summary

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