510(k) Report

Devices descending from K926453

759 later devices reach Synthes (U.S.a.) Anterior Cervical Vertebrae Plate through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K161524Tangis Anterior Cervical PlateNvision Biomedical Technologies, LLC20168—
+4K160702ZION Anterior Cervical Fixation SystemAstura Medical20163—
+4K160522White Pearl Preferred Angle Anterior Cervical PlateOsseus Fusion Systems, LLC20160—
+4K152793Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.201629—
+4K152632XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument AccessoryStryker Corporation201531—
+4K143688Asfora Anterior Cervical Plate SystemMedical Designs, LLC20150—
+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—
+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—
+4K122216Reliance Anterior Cervical Plate SystemReliance Medical Systems, LLC20123—
+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—
+4K111528Pioneer Aspect Anterior Cervical Plate Model 24-SeriesPioneer Surgical Technology, Inc.201111—
+4K100614Hallmark Anterior Cervcial Plate System, Hallmark Five-Level Cervical PlatesBlackstone Medical, Inc.201051—
+4K091396Cardo Medical Anterior Cervical Plate SystemCardo Medical Corp.20092—
+4K082037Seeplate Cervical Plate SystemAmedica Corp.20080—
+4K072703Pioneer Slimfuse Anterior Cervical Plating SystemPioneer Surgical Technology200819—
+4K043181Modification to Vertebron SCP Cervical Plate SystemVertebron, Inc.200411—
+4K040397Modification to Cyclone Anterior Cervical Plate SystemEncore Medical L.P.2004032
+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—
+5K260660SABER-C SystemElevation Spine20261—
+5K253260ORIO-3D Cage SystemSpineCraft20260—
+5K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+5K254182AsterOsteonic Co., Ltd.20260—
+5K253545Vulcan Spinal SystemK2m, Inc.20260—
+5K252461Swedge™ Pedicle Screw Fixation System Bezier RodSpinal Resources, Inc.20260—
+5K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+5K252611aprevo® cervical plating systemCarlsmed, Inc.20253—
+5K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+5K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting20250—
+5K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+5K250540SABER-C SystemElevation Spine20252—
+5K251436Resolve Anterior Cervical Plate SystemPioneer Surgical Technology, Inc.20250—
+5K250446Frida™ Anterior Cervical Plate SystemSpineup, Inc.20250—
+5K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+5K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+5K243004Xpine Spinal Fixation SystemJeil Medical Corporation20240—
+5K233215icotec Anterior Cervical Plate SystemIcotec AG20240—
+5K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+5K240690STRUXXURE® MCS Anterior Cervical Plate SystemNexxt Spine20244—
+5K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+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—
+5K231147Hammerdesis™ Interphalangeal Fusion SystemIntelivation20230—
+5K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+5K231840CastleLoc-S Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd.20230—
+5K231460FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System…K&J Consulting Corp.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—
+5K231145Axis Anterior Cervical Plate SystemSouthern Medical (Pty), Ltd.20230—
+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—
+5K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+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—
+5K223190Hive™ Standalone Cervical SystemNanoHive Medical, LLC20225—
+5K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+5K221728Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran™ Anterior…Stryker Corporation20221—
+5K221572VyPlate Anterior Cervical Plate SystemVy Spine, LLC20221—
+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—
+5K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+5K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+5K213456Xenco Medical Multilevel CerviKitXenco Medical, LLC20210—
+5K210424Quantum Anterior Cervical PlateNvision Biomedical Technologies, Inc.20214—
+5K203607MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20210—
+5K210382Blustone Synergy Diamond SA Cervical SystemBlustone Synergy, LLC20210—
+5K210549ARx Spinal SystemLife Spine, Inc.20211—
+5K203129NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) SystemPrecision Spine, Inc.20210—
+5K202657Javelin Tailor's Bunion Fixation SystemNvision Biomedical Technologies, Inc.20201—
+5K203253NuVasive ACP SystemNu Vasive, Incorporated20202—
+5K203076Mecta-C Stand Alone ExtensionMedacta International S.A.20200—
+5K200937ACURA Stabilization SystemIndius Medical Technologies Pvt., Ltd.20200—
+5K202528Cannulated Power Driver AttachmentK2m, Inc.20200—
+5K202065DOLOMITE Anterior Cervical Stabilization SystemAstura Medical, LLC20203—