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
K240662	03/08/2024	Spine Guidance Software (version 5.0); Xia 3/ Serrato Q Instruments; Everest Q Instruments; Mesa 2 Q Instruments; Q Pedicle Preparation Instruments; Q S2AI Drills; Q Handles; Consolidated Operating Room Equipment (CORE) 2 Console; Electric System 6 Dual T	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