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FDA 510(k) Applications Submitted by Andrea 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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