510(k) Report

Devices descending from K945700

692 later devices reach Synthes (Usa) Anterior Cervical Vertebrae Plate System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K180022Athena Cervical Plate SystemMedyssey USA, Inc.20182—
+4K181139OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20188—
+4K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+4K180210CREO® Stabilization SystemGlobus Medical, Inc.201888—
+4K173521SeaSpine Cabo ACP (Anterior Cervical Plate) SystemSeaSpine Orthopedics Corporation201815—
+4K172086Matira™ Anterior Cervical SystemKalitec Direct, LLC20170—
+4K163104Terrace™ Anterior Cervical Plate SystemCorelink, LLC201718—
+4K171112Trifore (tm) Cervical Plating SystemNeurostructures, Inc.20171—
+4K152632XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument AccessoryStryker Corporation201531—
+4K150036Blue Mountain Cervical Plate SystemSpineway20151—
+4K143684NuVasive Reline SystemNu Vasive, Incorporated201577—
+4K150647Polyscrew Pedicle Screw SystemNew Era Orthopedics, LLC201501
+4K143633CREO Stabilization SystemGlobus Medical, Inc.2015158—
+4K141253New Era Orthopaedics Polyscrew Pedicle Screw SystemNew Era Orthopaedics, LLC201511
+4K141993Nakoma AcpAlliance Partners, LLC201481
+4K142381Xia 3 Spinal SystemStryker Corp.201483—
+4K133366Orthros Posterior Stabilization SystemCamber Spine20142—
+4K133567Unify (R) Dynamic Anterior Cervical Plate SystemGlobus Medical, Inc.20145—
+4K133475Struxxure Anterior Cervical Plate and ScrewsNexxt Spine, LLC2013132—
+4K133188Mantis & Mantis Redux Spinal System, Radius Spinal System, Trio & Trio+ Spinal Fixation…Stryker Spine201384—
+4K132994Anodyne Anterior Cervical Plate SystemCorelink, LLC20131—
+4K131025Archon Anterior Cervical Plate SystemNuvasive, Inc.201397—
+4K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)201370—
+4K130825Azure Anterior Cervical Plate SystemOrthofix, Inc.201311
+4K130202Iris Anterior Cervical PlateLife Spine, Inc.201321—
+4K122226Revere Stabilization SystemGlobus Medical, Inc.2012225—
+4K121801Quintex Cervical Plating SystemAesculap Implant Systems, LLC20120—
+4K120838Synthes Matrix SystemSynthes Spine201216—
+4K121922Beacon Stabilization SystemGlobus Medical, Inc.20129—
+4K121852Synthes Zero-P Variable Angle (VA)Synthes Spine Co.Lp201230—
+4K121658Orthofix Acp (Anterior Cervical Plate System)Orthofix, Inc.20124—
+4K120646Capsure (R) PS SystemSpine Wave, Inc.20120—
+4K120928Synthes Matrix SystemSynthes Spine20120—
+4K120571Synthes Uss ConnectorSynthes Spine201274—
+4K100614Hallmark Anterior Cervcial Plate System, Hallmark Five-Level Cervical PlatesBlackstone Medical, Inc.201051—
+4K082037Seeplate Cervical Plate SystemAmedica Corp.20080—
+5K262149corra® cervical plating systemCarlsmed, Inc.20260—
+5K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—
+5K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+5K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+5K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.20260—
+5K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+5K254182AsterOsteonic Co., Ltd.20260—
+5K252461Swedge™ Pedicle Screw Fixation System Bezier RodSpinal Resources, Inc.20260—
+5K252826ARIX Femur Nail SystemJeil Medical Corporation20250—
+5K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+5K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+5K251436Resolve Anterior Cervical Plate SystemPioneer Surgical Technology, Inc.20250—
+5K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+5K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+5K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+5K243004Xpine Spinal Fixation SystemJeil Medical Corporation20240—
+5K233215icotec Anterior Cervical Plate SystemIcotec AG20240—
+5K240690STRUXXURE® MCS Anterior Cervical Plate SystemNexxt Spine20244—
+5K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+5K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+5K230961Zeus Spinal SystemShanghai Sanyou Medical Co, Ltd.20232—
+5K232605Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue®…Lesspine Innovations20230—
+5K231840CastleLoc-S Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd.20230—
+5K231841PathLoc SI Joint Fusion SystemL&K BIOMED Co., Ltd.20231—
+5K231636LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20232—
+5K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+5K223096Dark Star Deformity Pedicle Screw SystemRepublic Spine, LLC20231—
+5K230424Omnia Medical Coupler-A™ Anterior Lumbar Plate System; Omnia Medical Coupler-L™ Lateral…Omnia Medical, LLC20230—
+5K230301Athena III Cervical Plate SystemMedyssey USA, Inc.20230—
+5K230245LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20233—
+5K223521ZESPIN SI Joint Fusion SystemAegis Spine, Inc.20232—
+5K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+5K221050ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior…Aegis Spine, Inc.20226—
+5K212527Cervical Spine Truss System Plating Solution (CSTS-PS)4Web Medical, Inc.20220—
+5K220147Aspiron S ACP SystemU&I Corporation20220—
+5K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+5K203607MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20210—
+5K210549ARx Spinal SystemLife Spine, Inc.20211—
+5K203253NuVasive ACP SystemNu Vasive, Incorporated20202—
+5K200937ACURA Stabilization SystemIndius Medical Technologies Pvt., Ltd.20200—
+5K202528Cannulated Power Driver AttachmentK2m, Inc.20200—
+5K201521Medina Anterior Cervical Plate SystemAlliance Partners, LLC20200—
+5K201078NuVasive® ACP SystemNu Vasive, Incorporated20203—
+5K200245EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine SystemMedos International Sàrl202012—
+5K200666Stryker Xia 3 Power AdaptorStryker Spine20203—
+5K193494Origin™ Anterior Cervical Plate SystemOrthopaedic & Spine Development20200—
+5K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+5K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+5K191584FORTICO Anterior Cervical Fixation SystemCamber Spine Technologies, LLC20192—
+5K190016Lateral Plate SystemCorelink, LLC201915—
+5K182478Whistler Modular Pedicle Screw SystemEvolution Spine, LLC20196—
+5K182954Salvo™ Spine SystemSpine Wave, Inc.20186—
+5K180980ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization SystemCamber Spine Technologies, LLC20181—
+5K181821MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20181—
+5K173128Alamo® CAlliance Partners, LLC20182—
+5K173508Everest Spinal SystemK2m20189—
+5K172724XIA® 4.5 Spinal System, Power Adaptor Instrument AccessoryStryker Corporation20179—
+5K172275Vitality® Spinal Fixation System, Vitality®+ Power Instrument SystemZimmer Biomet Spine, Inc.20170—
+5K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart20179—
+5K172107Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System, Fortress™…Spineology, Inc.20170—
+5K171651Excelsius GPSGlobus Medical, Inc.2017691
+5K170496Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument AccessoryStryker Corporation2017151
+5K170266Palisade™ Pedicular Fixation SystemSpineology, Inc.20172—
+5K170255Threshold™ V2 Pedicular Fixation SystemSpineology, Inc.20171—