AXIEM IMAGELESS HIP MODULE FOR THE STEALTHSTATION SYSTEM

Neurological Stereotaxic Instrument

MEDTRONIC NAVIGATION, INC.

The following data is part of a premarket notification filed by Medtronic Navigation, Inc. with the FDA for Axiem Imageless Hip Module For The Stealthstation System.

Pre-market Notification Details

Device IDK061248
510k NumberK061248
Device Name:AXIEM IMAGELESS HIP MODULE FOR THE STEALTHSTATION SYSTEM
ClassificationNeurological Stereotaxic Instrument
Applicant MEDTRONIC NAVIGATION, INC. 826 COAL CREEK CIR. Louisville,  CO  80027
ContactTina Dreiling
CorrespondentTina Dreiling
MEDTRONIC NAVIGATION, INC. 826 COAL CREEK CIR. Louisville,  CO  80027
Product CodeHAW  
CFR Regulation Number882.4560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-05-03
Decision Date2006-08-31
Summary:summary

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