FDA 510(k) Applications Submitted by Andrea N Wallen-Gerding

FDA 510(k) Number Submission Date Device Name Applicant
K220593 03/01/2022 Spine Guidance Software, Stryker Q Guidance System Stryker Leibinger GmbH & Co. KG
K172034 07/05/2017 Stryker Spine Navigation System with SpineMap 3D software application, OrthoLock, nGenius Spine Clamp, Navigated Drill Guide Set, Navigated Xia 3 Awl Tap, Navigated Xia 3 Serrato Tap Stryker Corporation
K183196 11/19/2018 Stryker Navigation System with SpineMap Go Software Application, Fluoroscopy Trackers and Fluoroscopy Adapters, SpineMask Tracker Stryker Corporation
K142517 09/08/2014 SoftVue DELPHINUS MEDICAL TECHNOLOGIES, INC


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