510(k) Report

Devices descending from K022185

33 later devices reach Universal CMF System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K220360Tandry CMF Plate SystemMicroware Precision Co., Ltd.20220—
+1K221855Universal CMF SystemStryker Leibinger GmbH & Co KG20221—
+1K170773Stryker Universal MeshStryker20171—
+1K172572Stryker Upper-Face AXS screws and Mid-Face AXS screwsStryker20170—
+1K171364MP LeFort I PlatesStryker20170—
+1K161821Stryker Universal MeshStryker20162—
+1K091807Medpor Fixation SystemPorex Surgical, Inc.20100—
+1K080694Osteomed Modular Locking Fixation SystemOsteomed LP20082—
+1K072463Satyrne Interflex Mandibular Fixation SystemSatyrne Medical20070—
+1K041651Stryker Leibinger Skeletal Anchoring SystemStryker Leibinger20044—
+1K032520Ortrautek Trauma SystemTekka20030—
+1K031659Universal Neuro SystemStryker Instruments200312—
+2K240651MRI UniversalStryker Leibinger GmbH & Co KG20240—
+2K182609Delphos Implants Rigid Fixation SystemDelphos Implants - Ind.Com. Importacao E Exportacao DE20190—
+2K182425Universal Mesh - SterileStryker Leibinger GmbH & Co KG201801
+2K170725Stryker Universal MeshStryker20170—
+2K143338Argulated Locking PlatesOsteomed LP20150—
+2K141123Alliance Spine Raas Cranial Plating SystemAlliance Partners, LLC20150—
+2K112557Stryker Universal Neuro 3 SystemStryker20129—
+2K101835Medpor Fixation System-Cranial, Models 80080, 80079Porex Surgical, Inc.20100—
+2K091051Bollard Miniplate Skeletal Anchorage SystemTita-Link20091—
+2K063386Lorenz Orthodontic Anchorage SystemWalter Lorenz Surgical, Inc.20070—
+2K051798Osteomed Orthodontic Anchor Plating SystemOsteomed LP20060—
+3K192162NeuroVention Cranial Fixation System, NuCrani Plates, KTC Burr Hole Cover, DC PlateNeurovention, LLC20200—
+3K173623Anchor plateBiomaterials Korea, Inc.20180—
+3K151387Stryker Universal Neuro III System: UN III AXS Screw, UN III AXS Screwdriver BladeStryker20152—
+3K131775Universal Neuro 3 SystemStryker20130—
+3K120352Stryker Quikflap Sterile Procedure PackStryker2012418
+4K171152Stryker Universal Neuro III System AXS ScrewStryker20171—
+4K140309CranioplugOssdsign AB20142—
+5K231208Stryker Resorbable Fixation SystemStryker Leibinger GmbH & Co KG20230—
+5K181539OSSDSIGN CranioplugOssdsign AB20181—
+6K253447Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover)Orthocon, Inc.20260—