510(k) Report

Devices descending from K964328

35 later devices reach Synthes (Usa) Synthes MMFS-Adjustable Sagittal Split Plate through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K993862Modus Sagittal Split PlateThe Straumann Co.199934—
+2K022185Universal CMF SystemStryker Instruments200233—
+3K220360Tandry CMF Plate SystemMicroware Precision Co., Ltd.20220—
+3K221855Universal CMF SystemStryker Leibinger GmbH & Co KG20221—
+3K170773Stryker Universal MeshStryker20171—
+3K172572Stryker Upper-Face AXS screws and Mid-Face AXS screwsStryker20170—
+3K171364MP LeFort I PlatesStryker20170—
+3K161821Stryker Universal MeshStryker20162—
+3K091807Medpor Fixation SystemPorex Surgical, Inc.20100—
+3K080694Osteomed Modular Locking Fixation SystemOsteomed LP20082—
+3K072463Satyrne Interflex Mandibular Fixation SystemSatyrne Medical20070—
+3K041651Stryker Leibinger Skeletal Anchoring SystemStryker Leibinger20044—
+3K032520Ortrautek Trauma SystemTekka20030—
+3K031659Universal Neuro SystemStryker Instruments200312—
+4K240651MRI UniversalStryker Leibinger GmbH & Co KG20240—
+4K182609Delphos Implants Rigid Fixation SystemDelphos Implants - Ind.Com. Importacao E Exportacao DE20190—
+4K182425Universal Mesh - SterileStryker Leibinger GmbH & Co KG201801
+4K170725Stryker Universal MeshStryker20170—
+4K143338Argulated Locking PlatesOsteomed LP20150—
+4K141123Alliance Spine Raas Cranial Plating SystemAlliance Partners, LLC20150—
+4K112557Stryker Universal Neuro 3 SystemStryker20129—
+4K101835Medpor Fixation System-Cranial, Models 80080, 80079Porex Surgical, Inc.20100—
+4K091051Bollard Miniplate Skeletal Anchorage SystemTita-Link20091—
+4K063386Lorenz Orthodontic Anchorage SystemWalter Lorenz Surgical, Inc.20070—
+4K051798Osteomed Orthodontic Anchor Plating SystemOsteomed LP20060—
+5K192162NeuroVention Cranial Fixation System, NuCrani Plates, KTC Burr Hole Cover, DC PlateNeurovention, LLC20200—
+5K173623Anchor plateBiomaterials Korea, Inc.20180—
+5K151387Stryker Universal Neuro III System: UN III AXS Screw, UN III AXS Screwdriver BladeStryker20152—
+5K131775Universal Neuro 3 SystemStryker20130—
+5K120352Stryker Quikflap Sterile Procedure PackStryker2012418
+6K171152Stryker Universal Neuro III System AXS ScrewStryker20171—
+6K140309CranioplugOssdsign AB20142—
+7K231208Stryker Resorbable Fixation SystemStryker Leibinger GmbH & Co KG20230—
+7K181539OSSDSIGN CranioplugOssdsign AB20181—
+8K253447Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover)Orthocon, Inc.20260—