510(k) Report

Devices descending from K971883

531 later devices reach Synthes Spine Small Stature Anterior Cervical Vertebrae Plate System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K163061Altus Spine Cervical Plate SystemAltus Partners, LLC20171—
+3K161524Tangis Anterior Cervical PlateNvision Biomedical Technologies, LLC20168—
+3K160702ZION Anterior Cervical Fixation SystemAstura Medical20163—
+3K160522White Pearl Preferred Angle Anterior Cervical PlateOsseus Fusion Systems, LLC20160—
+3K152632XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument AccessoryStryker Corporation201531—
+3K143688Asfora Anterior Cervical Plate SystemMedical Designs, LLC20150—
+3K143684NuVasive Reline SystemNu Vasive, Incorporated201577—
+3K150647Polyscrew Pedicle Screw SystemNew Era Orthopedics, LLC201501
+3K143633CREO Stabilization SystemGlobus Medical, Inc.2015158—
+3K141253New Era Orthopaedics Polyscrew Pedicle Screw SystemNew Era Orthopaedics, LLC201511
+3K142381Xia 3 Spinal SystemStryker Corp.201483—
+3K133366Orthros Posterior Stabilization SystemCamber Spine20142—
+3K133567Unify (R) Dynamic Anterior Cervical Plate SystemGlobus Medical, Inc.20145—
+3K133188Mantis & Mantis Redux Spinal System, Radius Spinal System, Trio & Trio+ Spinal Fixation…Stryker Spine201384—
+3K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)201370—
+3K130825Azure Anterior Cervical Plate SystemOrthofix, Inc.201311
+3K130202Iris Anterior Cervical PlateLife Spine, Inc.201321—
+3K122226Revere Stabilization SystemGlobus Medical, Inc.2012225—
+3K122216Reliance Anterior Cervical Plate SystemReliance Medical Systems, LLC20123—
+3K120838Synthes Matrix SystemSynthes Spine201216—
+3K121922Beacon Stabilization SystemGlobus Medical, Inc.20129—
+3K121852Synthes Zero-P Variable Angle (VA)Synthes Spine Co.Lp201230—
+3K121658Orthofix Acp (Anterior Cervical Plate System)Orthofix, Inc.20124—
+3K120646Capsure (R) PS SystemSpine Wave, Inc.20120—
+3K120928Synthes Matrix SystemSynthes Spine20120—
+3K120571Synthes Uss ConnectorSynthes Spine201274—
+3K111528Pioneer Aspect Anterior Cervical Plate Model 24-SeriesPioneer Surgical Technology, Inc.201111—
+3K100614Hallmark Anterior Cervcial Plate System, Hallmark Five-Level Cervical PlatesBlackstone Medical, Inc.201051—
+3K091396Cardo Medical Anterior Cervical Plate SystemCardo Medical Corp.20092—
+3K072703Pioneer Slimfuse Anterior Cervical Plating SystemPioneer Surgical Technology200819—
+3K043181Modification to Vertebron SCP Cervical Plate SystemVertebron, Inc.200411—
+3K040397Modification to Cyclone Anterior Cervical Plate SystemEncore Medical L.P.2004032
+4K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+4K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+4K251940PathLoc Lumbar Plate SystemL&K BIOMED Co., Ltd.20260—
+4K253545Vulcan Spinal SystemK2m, Inc.20260—
+4K252461Swedge™ Pedicle Screw Fixation System Bezier RodSpinal Resources, Inc.20260—
+4K252826ARIX Femur Nail SystemJeil Medical Corporation20250—
+4K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+4K251436Resolve Anterior Cervical Plate SystemPioneer Surgical Technology, Inc.20250—
+4K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+4K250446Frida™ Anterior Cervical Plate SystemSpineup, Inc.20250—
+4K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+4K243004Xpine Spinal Fixation SystemJeil Medical Corporation20240—
+4K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+4K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+4K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+4K230961Zeus Spinal SystemShanghai Sanyou Medical Co, Ltd.20232—
+4K231839CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd.20232—
+4K231636LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20232—
+4K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+4K223096Dark Star Deformity Pedicle Screw SystemRepublic Spine, LLC20231—
+4K230301Athena III Cervical Plate SystemMedyssey USA, Inc.20230—
+4K230245LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20233—
+4K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+4K220843OAKTREE Anterior Lumbar Plate and Screw SystemOak Tree Engineering, LLC20220—
+4K221728Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran™ Anterior…Stryker Corporation20221—
+4K221572VyPlate Anterior Cervical Plate SystemVy Spine, LLC20221—
+4K220147Aspiron S ACP SystemU&I Corporation20220—
+4K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+4K213456Xenco Medical Multilevel CerviKitXenco Medical, LLC20210—
+4K210424Quantum Anterior Cervical PlateNvision Biomedical Technologies, Inc.20214—
+4K212139Admiral ACP SystemSeaSpine Orthopedics Corporation20216—
+4K211903Shoreline Threaded TruProfile® PlateSeaSpine Orthopedics Corporation20217—
+4K203607MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20210—
+4K211932Fixxsure Anterior Lumbar Plate and Screw SystemOak Tree Engineering, LLC20211—
+4K210549ARx Spinal SystemLife Spine, Inc.20211—
+4K210035ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix…Aegis Spine202110—
+4K202657Javelin Tailor's Bunion Fixation SystemNvision Biomedical Technologies, Inc.20201—
+4K200937ACURA Stabilization SystemIndius Medical Technologies Pvt., Ltd.20200—
+4K202528Cannulated Power Driver AttachmentK2m, Inc.20200—
+4K202064Admiral ACP SystemSeaSpine Orthopedics Corporation202014—
+4K200245EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine SystemMedos International Sàrl202012—
+4K200666Stryker Xia 3 Power AdaptorStryker Spine20203—
+4K193494Origin™ Anterior Cervical Plate SystemOrthopaedic & Spine Development20200—
+4K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+4K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+4K192494NexGen Anterior Cervical Plate SystemPrecision Spine20190—
+4K191584FORTICO Anterior Cervical Fixation SystemCamber Spine Technologies, LLC20192—
+4K183084Fuji Cervical Plate SystemAltus Partners, LLC20190—
+4K182478Whistler Modular Pedicle Screw SystemEvolution Spine, LLC20196—
+4K182954Salvo™ Spine SystemSpine Wave, Inc.20186—
+4K180980ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization SystemCamber Spine Technologies, LLC20181—
+4K181821MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20181—
+4K173508Everest Spinal SystemK2m20189—
+4K173091Boundary Anterior Lumbar Buttress PlateNvision Biomedical Technologies, LLC20170—
+4K172724XIA® 4.5 Spinal System, Power Adaptor Instrument AccessoryStryker Corporation20179—
+4K172275Vitality® Spinal Fixation System, Vitality®+ Power Instrument SystemZimmer Biomet Spine, Inc.20170—
+4K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart20179—
+4K172107Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System, Fortress™…Spineology, Inc.20170—
+4K171651Excelsius GPSGlobus Medical, Inc.2017691
+4K163104Terrace™ Anterior Cervical Plate SystemCorelink, LLC201718—
+4K170496Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument AccessoryStryker Corporation2017151
+4K170266Palisade™ Pedicular Fixation SystemSpineology, Inc.20172—
+4K170255Threshold™ V2 Pedicular Fixation SystemSpineology, Inc.20171—
+4K170251Threshold™ Pedicular Fixation SystemSpineology, Inc.20171—
+4K170268Fortress™ Pedicular Fixation SystemSpineology, Inc.20171—
+4K163604SeaSpine® Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation201712—
+4K161014NuVasive® Reline® SystemNu Vasive, Incorporated201648—
+4K160989NuVasive® Reline® SystemNu Vasive, Incorporated201667—