510(k) Report

Devices descending from K062358

34 later devices reach Modification to Vectorvision Trauma through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K130887S4C Navigation InstrumentsAesculap Implant System, Inc.201313—
+1K110204Brainlab TraumaBrainlab AG201127—
+1K103400Fluoromap Software, 9 Fluorodisc (Belt), 12 Fluoro Disc (Belt), Close Tube ClipStryker Corporation20115—
+2K221618Spine & Trauma Navigation, Spine Navigation, Navigation Software Spine & Trauma…Brainlab AG20226—
+2K182359HipCheckStryker Corp.20181—
+2K181890Brainlab Compatible K2M Navigation InstrumentsK2m201811—
+2K173946ADAPT for Gamma3Stryker GmbH20182—
+2K153700Aesculap (R) Implant Systems (AIS) S4 Navigation InstrumentsAesculap Implant Systems, LLC20160—
+2K122011Navigation Software Hip-Universal; Navigation Software Hip THR-AesculapBrainlab AG201251
+3K262257Spine Planning (3.0); Spine & Trauma Navigation; Alignment System SpineBrainlab SE20260—
+3K252562Spine & Trauma Navigation InstrumentsBrainlab AG20250—
+3K242569Mixed Reality Spine NavigationBrainlab AG20250—
+3K241893CROSSNAV Navigation Enabled Instruments and UNAS Navigation ArraysMedos International SARL20241—
+3K240701Drill Guide; Drill Bit; Spine & Trauma NavigationBrainlab AG20240—
+3K230045HipCheckStryker Corp.20230—
+3K201006K2M Navigation InstrumentsK2m, Inc.20200—
+3K193307HIP7Brainlab AG20200—
+3K192911Brainlab Compatible K2M Navigation InstrumentsK2m, Inc.20199—
+3K181848ADAPT for Gamma3, Gamma3Stryker GmbH20181—
+3K181449Ortoma Treatment Solution - OTSOrtoma AB20183—
+4K254157CROSSNAV Navigation Enabled Instruments for Disc Preparation and InterbodyMedos International SARL20260—
+4K232140OTS HipOrtoma AB202421
+4K203205Navigated Spine InstrumentsStryker Spine20218—
+4K202749ADAPT for Gamma3Stryker GmbH20200—
+5K250086OTS HipOrtoma AB202511
+5K240662Spine Guidance Software (version 5.0); Xia 3/ Serrato Q Instruments; Everest Q…Stryker Leibinger GmbH & Co KG20247—
+6K261852OTS HipOrtoma AB20260—
+6K260546Q Pedicle InstrumentsK2m, Inc.20260—
+6K252873Q Interbody InstrumentsK2m, Inc.20260—
+6K252871Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments; Elite Cutting…Stryker Leibinger GmbH & Co KG20261—
+6K241171Spine Guidance Software (Version 5.1); Consolidated Operating Room Equipment (CORE) 2…Stryker Leibinger GmbH & Co KG20244—
+7K253623Spine Guidance 5.4 Software; Spine Guidance 5.4 Upgrade; Spine Guidance 5.4 Update…Stryker Leibinger GmbH & Co KG20260—
+7K243958Consolidated Operating Room Equipment (CORE) 2 ConsoleStryker Instruments20250—
+7K241517Q Guidance System; Mako Spine System;Stryker Leibinger GmbH & Co KG20242—