Stryker Navigation System With SpineMap Go Software Application, Fluoroscopy Trackers And Fluoroscopy Adapters, SpineMask Tracker

Orthopedic Stereotaxic Instrument

Stryker Corporation

The following data is part of a premarket notification filed by Stryker Corporation with the FDA for Stryker Navigation System With Spinemap Go Software Application, Fluoroscopy Trackers And Fluoroscopy Adapters, Spinemask Tracker.

Pre-market Notification Details

Device IDK183196
510k NumberK183196
Device Name:Stryker Navigation System With SpineMap Go Software Application, Fluoroscopy Trackers And Fluoroscopy Adapters, SpineMask Tracker
ClassificationOrthopedic Stereotaxic Instrument
Applicant Stryker Corporation Boetzinger Strasse 41 Freiburg,  DE D-79111
ContactAndrea Wallen-gerding
CorrespondentAndrea Wallen-gerding
Stryker Corporation Boetzinger Strasse 41 Freiburg,  DE D-79111
Product CodeOLO  
CFR Regulation Number882.4560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-11-19
Decision Date2019-02-14
Summary:summary

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