X-Guide Surgical Navigation System

Dental Stereotaxic Instrument

X-Nav Technologies, LLC

The following data is part of a premarket notification filed by X-nav Technologies, Llc with the FDA for X-guide Surgical Navigation System.

Pre-market Notification Details

Device IDK192579
510k NumberK192579
Device Name:X-Guide Surgical Navigation System
ClassificationDental Stereotaxic Instrument
Applicant X-Nav Technologies, LLC 1555 Bustard Road, Suite 75 Lansdale,  PA  19446
ContactFred Cowdery
CorrespondentFred Cowdery
X-Nav Technologies, LLC 1555 Bustard Road, Suite 75 Lansdale,  PA  19446
Product CodePLV  
CFR Regulation Number872.4120 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyDental
510k Review PanelDental
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-09-19
Decision Date2020-02-03

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