Synergy Cranial

Neurological Stereotaxic Instrument

MEDTRONIC NAVIGATION, INC.

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

Pre-market Notification Details

Device IDK150216
510k NumberK150216
Device Name:Synergy Cranial
ClassificationNeurological Stereotaxic Instrument
Applicant MEDTRONIC NAVIGATION, INC. 826 COAL CREEK CIRCLE Louisville,  CO  80027
ContactKaye E. Waite
CorrespondentKaye E. Waite
MEDTRONIC NAVIGATIONS, INC. 826 COAL CREEK CIRCLE Louisville,  CO  80027
Product CodeHAW  
CFR Regulation Number882.4560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-01-30
Decision Date2015-06-11
Summary:summary

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