510(k) Report

Devices descending from K022012

17 later devices reach Synthes Low Profile Neuro System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K192702DePuy Synthes Craniomaxillofacial Neuro Devices - MR ConditionalSynthes (USA) Products, LLC20200—
+1K192655Depuy Synthes Maxillofacial Portfolio - MR ConditionalSynthes (USA) Products, LLC20190—
+1K123723Synthes Matrixneuro Cranial Plating SystemSynthes20132—
+1K112557Stryker Universal Neuro 3 SystemStryker20129—
+1K101835Medpor Fixation System-Cranial, Models 80080, 80079Porex Surgical, Inc.20100—
+1K031659Universal Neuro SystemStryker Instruments200312—
+2K192162NeuroVention Cranial Fixation System, NuCrani Plates, KTC Burr Hole Cover, DC PlateNeurovention, LLC20200—
+2K151387Stryker Universal Neuro III System: UN III AXS Screw, UN III AXS Screwdriver BladeStryker20152—
+2K141123Alliance Spine Raas Cranial Plating SystemAlliance Partners, LLC20150—
+2K140462Matrixneuro Preformed Mesh (Part of the Matrixneuro Cranial Plating System)Synthes (USA) Products, LLC20141—
+2K131775Universal Neuro 3 SystemStryker20130—
+2K120352Stryker Quikflap Sterile Procedure PackStryker2012418
+3K171152Stryker Universal Neuro III System AXS ScrewStryker20171—
+3K140309CranioplugOssdsign AB20142—
+4K231208Stryker Resorbable Fixation SystemStryker Leibinger GmbH & Co KG20230—
+4K181539OSSDSIGN CranioplugOssdsign AB20181—
+5K253447Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover)Orthocon, Inc.20260—