510(k) Report

Devices descending from K963741

188 later devices reach Leibinger Luhr Small Craniomaxillofacial Bone Screws through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K032534Synthes AfsSynthes Spine200443—
+1K970912Leibinger Self-Drilling ScrewHowmedica Leibinger, Inc.1997143—
+2K252930AQUA Laminoplasty SystemsZheJiang Decans Medical Devices Co., Ltd.20260—
+2K232471Vy Spine™ VyLam™ Laminoplasty SystemVy Spine, LLC20231—
+2K231232Curiteva Laminoplasty SystemCuriteva, Inc.20232—
+2K191927Hinged Laminoplasty SystemLife Spine, Inc.20190—
+2K181717Life Spine Laminoplasty SystemLife Spine, Inc.20181—
+2K173215Choice Spine Laminoplasty™ Fixation SystemChoicespine, LP20184—
+2K132740Spinefrontier Lesplasty Posterior Cervical Laminoplasty SystemSpinefrontier, Inc.20130—
+2K122822Spectrum Spine Laminoplasty Plating SystemSpectrum Spine, LLC20135—
+2K121276Neuro Vention Laminplasty Plating SystemNeurovention, LLC20120—
+2K111048Synthes Scout Tack FixationSynthes Spine20120—
+2K113802Escalate Laminoplasty SystemStryker Spine20127—
+2K103284Laminoplasy Plating SystemAesculap Implant Systems, Inc.20101—
+2K100805Gallery Laminoplasty Fixation SystemBiomet Spine (Aka Ebi, LLC)20103—
+2K091994Mountaineer Laminoplasty SystemDepuy Spine, Inc.201017—
+2K091623Laminoplasty Fixation SystemNuvasive, Inc.20097—
+2K090354Laminoplasty Plating SystemAesculap Implant System, Inc.20092—
+2K080664Relieve Laminoplasty Fixation SystemGlobus Medical, Inc.200811—
+2K073342Salvin Dental Specialties, Inc., Fixation ScrewSalvin Dental Specialties, Inc.20085—
+2K043338Blakstone Laminoplasty Fixation SystemBlackstone Medical, Inc.200517—
+2K0232601.2MM Osteomed Auto-Drive Screw SystemOsteomed Corp.200224—
+2K992106Modus System Self-Drilling ScrewsMedartis AG19990—
+2K974785Auto-Drive Bone ScrewOsteomed Corp.1998141—
+3K243137Curiteva Porous PEEK Laminoplasty SystemCuriteva, Inc.20241—
+3K242784Vy Spine™ VyLam™ Laminoplasty SystemVy Spine, LLC20240—
+3K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+3K2117123° Anterior Cervical Plating System, Reliant Anterior Cervical Plating System, Unity…Orthofix US, LLC20220—
+3K202309Epic Anterior Thoracolumbar Plate System, Gallery Laminoplasty Fixation System, Concero…Zimmer Biomet Spine, Inc.20200—
+3K192281AEGIS Anterior Lumbar Plate System, ALC Dynamized Fixation System, Anterior ISOLA Spine…Medos International SARL20190—
+3K181846ASSURE Anterior Cervical Plate System, PROVIDENCE Anterior Cervical Plate System, VIP…Globus Medical, Inc.20184—
+3K180156SP-Fix® Spinous Process Fixation Plate, RELIEVE® Laminoplasty Fixation SystemGlobus Medical, Inc.20185—
+3K171413HAVEN™ Laminoplasty System, CANOPY® Laminoplasty Fixation SystemGlobus Medical, Inc.20176—
+3K160114Xspan Laminoplasty Fixation SystemX-Spine Systems, Inc.20160—
+3K153735Release Laminoplasty Fixation SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20160—
+3K151195OsteoMed IMF ScrewOsteomed20150—
+3K141764Tristar Bone Graft Fixation SystemImpladent, Ltd.20143—
+3K130830Integra Laminoplasty SystemSeaspine, Inc.20132—
+3K122049Neuropro Low Profile Cranial Plating SystemKinamed, Inc.20130—
+3K121732Canopy Laminoplasty Fixation SystemGlobus Medical, Inc.201210—
+3K113218Pioneer Release Laminoplasty Plating SystemPioneer Surgical Technology, Inc.20121—
+3K103084Neodent Graft ScrewJjgc Industria E Comercio DE Materiais Dentarios S20110—
+3K071035Ifs Bone Fixation DevicesInternal Fixation Systems, Inc.20073—
+3K063589Gso Bone Fixation FastenersGold Standard Orthopaedics, LLC20074—
+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—
+4K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+4K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+4K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+4K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+4K191584FORTICO Anterior Cervical Fixation SystemCamber Spine Technologies, LLC20192—
+4K170697GBR systemSurgident20182—
+4K150469Integra Laminoplasty SystemSeaspine, Inc.20151—
+4K141123Alliance Spine Raas Cranial Plating SystemAlliance Partners, LLC20150—
+4K140216Orthopedic Fixation SystemsImpact Medical, LLC20140—
+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—
+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—
+5K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+5K253545Vulcan Spinal SystemK2m, Inc.20260—
+5K252758Cannulated Screw and Kirschner (K wire) SystemOrthonovis, Inc.20250—
+5K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+5K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+5K222367Save GBRDentis Co., Ltd.20230—
+5K211205Prase-C Anterior Cervical Plate SystemGbs Commonwealth Co., Ltd.20210—
+5K182759BoniPlus Dental G-Mesh SystemMontjade Engineering Co., Ltd.20200—
+5K192162NeuroVention Cranial Fixation System, NuCrani Plates, KTC Burr Hole Cover, DC PlateNeurovention, LLC20200—
+5K182609Delphos Implants Rigid Fixation SystemDelphos Implants - Ind.Com. Importacao E Exportacao DE20190—
+5K151387Stryker Universal Neuro III System: UN III AXS Screw, UN III AXS Screwdriver BladeStryker20152—
+5K140037Optimus CMF SystemOsteonic Co., Ltd.20152—
+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—
+6K253373Southern Craniomaxillofacial (CMF) SystemSouthern Medical (Pty), Ltd.20250—
+6K252661SternaFuse Ti Fixation SystemFusion Innovations, LLC20250—
+6K202914SternaFuse Fixation SystemFusion Innovations, LLC20221—
+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—
+6K160363Optimus CMF SystemOsteonic Co., Ltd.20160—
+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—