MEDTRONIC ORTHOPAEDIC TRAUMA APPLICATION

Neurological Stereotaxic Instrument

MEDTRONIC NAVIGATION, INC.

The following data is part of a premarket notification filed by Medtronic Navigation, Inc. with the FDA for Medtronic Orthopaedic Trauma Application.

Pre-market Notification Details

Device IDK050651
510k NumberK050651
Device Name:MEDTRONIC ORTHOPAEDIC TRAUMA APPLICATION
ClassificationNeurological Stereotaxic Instrument
Applicant MEDTRONIC NAVIGATION, INC. 826 COAL CREEK CIRCLE Lousville,  CO  80027
ContactTina Dreiling
CorrespondentTina Dreiling
MEDTRONIC NAVIGATION, INC. 826 COAL CREEK CIRCLE Lousville,  CO  80027
Product CodeHAW  
CFR Regulation Number882.4560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-03-14
Decision Date2005-07-27
Summary:summary

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