FDA 510(k) Applications Submitted by ANDREA N WALLEN
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K080034 |
01/07/2008 |
THREE STAGE VENOUS RETURN CANNULA, MODEL 816460 |
TERUMO CARDIOVASCULAR SYSTEMS CORP. |
| 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 |
| K123209 |
10/12/2012 |
SOFTVUE |
DELPHINUS MEDICAL TECHNOLOGIES, INC |
| K142517 |
09/08/2014 |
SoftVue |
DELPHINUS MEDICAL TECHNOLOGIES, INC |
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