510(k) Report

Devices descending from K963740

167 later devices reach Leibinger - Luhr Small Mandibular Bone Screws through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K970912Leibinger Self-Drilling ScrewHowmedica Leibinger, Inc.1997143—
+1K963030Leibinger Imf ScrewHowmedica Leibinger, Inc.199725—
+2K140037Optimus CMF SystemOsteonic Co., Ltd.20152—
+2K073342Salvin Dental Specialties, Inc., Fixation ScrewSalvin Dental Specialties, Inc.20085—
+2K050478Medicon Imf-Orion ScrewsMedicon EG20050—
+2K050535Stryker MMF ScrewStryker Instruments200511—
+2K0232601.2MM Osteomed Auto-Drive Screw SystemOsteomed Corp.200224—
+2K980760KLS-Martin MMF ScrewKLS-Martin L.P.19998—
+2K992106Modus System Self-Drilling ScrewsMedartis AG19990—
+2K983728Lorenz Imf ScrewWalter Lorenz Surgical, Inc.19999—
+2K974785Auto-Drive Bone ScrewOsteomed Corp.1998141—
+3K253373Southern Craniomaxillofacial (CMF) SystemSouthern Medical (Pty), Ltd.20250—
+3K160363Optimus CMF SystemOsteonic Co., Ltd.20160—
+3K151195OsteoMed IMF ScrewOsteomed20150—
+3K141764Tristar Bone Graft Fixation SystemImpladent, Ltd.20143—
+3K122049Neuropro Low Profile Cranial Plating SystemKinamed, Inc.20130—
+3K122313Stryker Universal Smartlock Hybrid MMF SystemStryker201210—
+3K103084Neodent Graft ScrewJjgc Industria E Comercio DE Materiais Dentarios S20110—
+3K071035Ifs Bone Fixation DevicesInternal Fixation Systems, Inc.20073—
+3K063386Lorenz Orthodontic Anchorage SystemWalter Lorenz Surgical, Inc.20070—
+3K063589Gso Bone Fixation FastenersGold Standard Orthopaedics, LLC20074—
+3K051871Stoma Bone ScrewStorz AM Mark GmbH20051—
+3K042573KLS Martin Drill-Free MMF ScrewKLS-Martin L.P.20044—
+3K040983Lorenz Self-Drilling Imf ScrewWalter Lorenz Surgical, Inc.20047—
+3K031659Universal Neuro SystemStryker Instruments200312—
+3K030806Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial SurgeryBioplate, Inc.20035—
+3K022890Modified Screw Designs for Use with the Bioplate Rigid Fixation Bone Plating System for…Bioplate, Inc.20027—
+3K013954Lorenz Self Drilling ScrewsWalter Lorenz Surgical, Inc.2002117—
+4K252246Leforte MMF SystemJeil Medical Corporation20260—
+4K241314KLS Martin Oral-Max Implants MR Conditional (bundled)KLS-Martin L.P.20241—
+4K231599Stryker MP, Mandible, HMMF and MMF AXS ScrewsStryker Leibinger GmbH & Co KG20230—
+4K170697GBR systemSurgident20182—
+4K173320KLS Martin L1 MMF SystemKLS Martin L.P.20182—
+4K143336Biomet Microfixation OmniMax MMF SystemBiomet Microfixation20155—
+4K141123Alliance Spine Raas Cranial Plating SystemAlliance Partners, LLC20150—
+4K141165Matrixwave MMF SystemSynthes (USA) Products, LLC20144—
+4K140216Orthopedic Fixation SystemsImpact Medical, LLC20140—
+4K132212Dental Bone Screws; Dental Bone Screws, Continuing; Screw System TX; Screw System TX…Hager& Meisinger GmbH20140—
+4K130613Cannulated Screw and Kirschner (Kwire) SystemLaura Cattabriga20141—
+4K121589Biomet Microfixation Facial Plating SystemBiomet Microfixation201251
+4K112557Stryker Universal Neuro 3 SystemStryker20129—
+4K101835Medpor Fixation System-Cranial, Models 80080, 80079Porex Surgical, Inc.20100—
+4K091812Frontier Devices Craniomaxillofacial, Cranio Closure, Orthognathic, Mandible…Frontier Devices, Inc.20104—
+4K083432Drill Free MMF ScrewKLS Martin L.P.20093—
+4K063506Lorenz Sternal Closure SystemWalter Lorenz Surgical, Inc.200687—
+4K032228Lorenz 2.4 Self Drilling ScrewsWalter Lorenz Surgical, Inc.2003101—
+4K031751Rapidfire Self Drilling ScrewsWalter Lorenz Surgical, Inc.200301
+4K031028The Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial SurgeryBioplate, Inc.20030—
+5K260137KLS Martin IPS Oral-Max Implants - MR Conditional; Individual Patient Solutions - Ti…KLS-Martin L.P.20260—
+5K252758Cannulated Screw and Kirschner (K wire) SystemOrthonovis, Inc.20250—
+5K233721KLS Martin Drill-Free MMF ScrewKLS-Martin L.P.20240—
+5K222367Save GBRDentis Co., Ltd.20230—
+5K182759BoniPlus Dental G-Mesh SystemMontjade Engineering Co., Ltd.20200—
+5K192162NeuroVention Cranial Fixation System, NuCrani Plates, KTC Burr Hole Cover, DC PlateNeurovention, LLC20200—
+5K192655Depuy Synthes Maxillofacial Portfolio - MR ConditionalSynthes (USA) Products, LLC20190—
+5K182609Delphos Implants Rigid Fixation SystemDelphos Implants - Ind.Com. Importacao E Exportacao DE20190—
+5K152326Biomet Microfixation OmniMax MMF SystemBiomet Microfixation20151—
+5K151387Stryker Universal Neuro III System: UN III AXS Screw, UN III AXS Screwdriver BladeStryker20152—
+5K131775Universal Neuro 3 SystemStryker20130—
+5K132600Facial Prebent Plating with Virtual Surgical PlanningBiomet Microfixation20130—
+5K120352Stryker Quikflap Sterile Procedure PackStryker2012418
+5K111908Biomet Microfixation Sternal Closure SystemBiomet Microfixation, Inc.201178—
+5K110574Biomet Microfixation Sternalock Blu Sternal Closure SystemBiomet Microfixation, Inc.2011841
+5K110039Biomet Sports Medicine Sternal Closure SystemBiomet Sports Medicine20111—
+5K033740Lorenz Sternal Closure SystemWalter Lorenz Surgical, Inc.2003100—
+6K252661SternaFuse Ti Fixation SystemFusion Innovations, LLC20250—
+6K202914SternaFuse Fixation SystemFusion Innovations, LLC20221—
+6K202969Biomet Microfixation OmniMax MMF SystemBiomet Microfixation20210—
+6K202889Able Medical Devices Valkyrie Thoracic Fixation SystemJm Longyear Manufacturing, LLC D.B.A. Able Medical Devices202139—
+6K191030Applied Biosystems™ 3500 Dx Genetic Analyzer and Applied Biosystems™ 3500xL Dx Genetic…Life Technologies Corporation20200—
+6K181806ARIX Sternal SystemJeil Medical Corporation20180—
+6K173579Thorecon™ Fixation SystemA & E Medical Corporation20181—
+6K171152Stryker Universal Neuro III System AXS ScrewStryker20171—
+6K150581Tritium Sternal Cable Plate SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)201544—
+6K142484Sternal Closure SystemJace Medical, LLC20141—
+6K140309CranioplugOssdsign AB20142—
+6K133785Tritium Sternal Cable Plate SystemPioneer Surgical Technology, Inc.2014451
+6K122293Pioneer Sternal Cable Plate SystemPioneer Surgical Technology, Inc.201246—
+6K121302Biomet Microfixation Sternal Closure SystemBiomet Microfixation201275—
+6K051165KLS Martin Sternal TalonKLS-Martin L.P.200662—
+6K053624Medicon Stern-a-Fix Sternal Closure SystemMedicon EG20060—
+7K241018KLS Martin Orthopedic Implants - MR ConditionalKLS-Martin L.P.20241—
+7K232515Valkyrie Thoracic Fixation SystemJm Longyear Manufacturing, LLC D/B/A Able Medical Devices20230—
+7K231208Stryker Resorbable Fixation SystemStryker Leibinger GmbH & Co KG20230—
+7K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+7K211695Valkyrie Thoracic Fixation SystemJm Longyear Manufacturing, LLC D/B/A Able Medical Devices20211—
+7K210290JACE Medical Thoracic Plating SystemJace Medical, LLC20210—
+7K183172Stryker SternalPlate SystemStryker20191—
+7K181539OSSDSIGN CranioplugOssdsign AB20181—
+7K181607Thorecon Rigid Fixation SystemA & E Medical Corporation201805
+7K161876Tritium® Sternal Cable Plate SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.201643—
+7K161896Biomet Microfixation Sternal Closure SystemBiomet Microfixation20164—
+7K151019SternaLock® 360 Sternal Closure SystemBiomet Microfixation201543—
+7K142823Biomet Microfixation Thoracic Fixation SystemBiomet Microfixation201523—
+7K122860KLS Martin Recon TalonKLS Martin L.P.201210—
+7K070169KLS Martin Quick Disc, Sternal Talon and Sternal Plating - SterileKLS Martin L.P.200761—
+8K253447Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover)Orthocon, Inc.20260—
+8K250988KLS Martin Pure Pectus SystemKLS-Martin L.P.20250—
+8K243491SternalPlate ExpansionStryker Leibinger GmbH & Co KG20240—
+8K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—