510(k) Report

Devices descending from K112557

9 later devices reach Stryker Universal Neuro 3 System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K192162NeuroVention Cranial Fixation System, NuCrani Plates, KTC Burr Hole Cover, DC PlateNeurovention, LLC20200—
+1K151387Stryker Universal Neuro III System: UN III AXS Screw, UN III AXS Screwdriver BladeStryker20152—
+1K131775Universal Neuro 3 SystemStryker20130—
+1K120352Stryker Quikflap Sterile Procedure PackStryker2012418
+2K171152Stryker Universal Neuro III System AXS ScrewStryker20171—
+2K140309CranioplugOssdsign AB20142—
+3K231208Stryker Resorbable Fixation SystemStryker Leibinger GmbH & Co KG20230—
+3K181539OSSDSIGN CranioplugOssdsign AB20181—
+4K253447Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover)Orthocon, Inc.20260—