510(k) Report

Devices descending from K972718

221 later devices reach M-2 Anterior Plate System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K192281AEGIS Anterior Lumbar Plate System, ALC Dynamized Fixation System, Anterior ISOLA Spine…Medos International SARL20190—
+1K133194Diamond Rattlesnake SystemEminent Spine201417—
+1K131533Cayman MI Plate SystemK2m, Inc.201372—
+1K052546Aegis Anterior Lumbar Plate SystemDepuy Spine, Inc.2006211—
+1K033148Art Anterior Spinal SystemAdvanced Medical Technologies AG20040—
+2K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+2K232318VICTORY™ Lumbar Plate SystemGlobus Medical, Inc.20230—
+2K201079Aurora® Anterior Lumbar Plate SytstemPrism Surgical Design Pty, Ltd.20200—
+2K190016Lateral Plate SystemCorelink, LLC201915—
+2K182473PYRENEES Cervical Plate System, BLUE RIDGE Cervical Plate System, OZARK Cervical Plate…K2m, Inc.20184—
+2K173885Genesys Spine Binary Lumbar Plate SystemGenesys Spine20184—
+2K172941CASCADIA Interbody SystemK2m201852—
+2K1721312 Hole Lateral Plating SystemLife Spine, Inc.201710—
+2K163625NOOSA Anterior Lumbar Plate System;NAMBUCCA Anterior Lumbar Plate System; CAIRNS…Signature Orthopaedics Pty, Ltd.20172—
+2K162211AccuFit Lateral Plate SystemPrecision Spine, Inc.20164—
+2K153097Belvedere™ Lateral Plating SystemNeurostructures, Inc.20160—
+2K121791Zou Anterior Lumbar Plate SystemCorelink, LLC2012113—
+2K111866Nuvasive Anterior Lumbar Plate SystemNuvasive, Inc.201135—
+2K070922Modification to Spinal Usa VBR SystemSpinal USA2007161—
+3K251940PathLoc Lumbar Plate SystemL&K BIOMED Co., Ltd.20260—
+3K253545Vulcan Spinal SystemK2m, Inc.20260—
+3K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+3K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+3K233360Curiteva Thoracolumbar Plate SystemCuriteva, Inc.20240—
+3K231715MONDRIAN™ Anterior Lumbar Plate SystemCtl Medical Corporation20240—
+3K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+3K232154MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate FixationMiRus, LLC20230—
+3K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+3K222806Kodiak C Spinal Implant SystemMet One Technologies, LLC20221—
+3K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc.20221—
+3K221728Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran™ Anterior…Stryker Corporation20221—
+3K220324AccuFit Lateral 2-Hole PlatePrecision Spine, Inc.20223—
+3K212937Dakota ALIF Plate SystemPrecision Spine, Inc.20210—
+3K203065Lumbar Spine Truss System Plating Solution (LSTS-PS)4Web, Inc.20219—
+3K202192STRUXXURE®-L and STRUXXURE®-A Plate SystemNexxt Spine, LLC20200—
+3K192678Genesys Spine Binary® Lumbar Plate SystemGenesys Spine20191—
+3K191354Ti3Z Cervical Interbody SystemZavation Medical Products, LLC201913—
+3K181190Pinehurst Anterior Cervical Plate SystemSignature Orthopaedics Pty, Ltd.20190—
+3K182210TiWAVE-L Porous Titanium Lumbar CageKalitec Medical, LLC20193—
+3K183214Raven Lumbar Plate SystemChoicespine, LP20192—
+3K182746ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc.2018110—
+3K181347Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC201824—
+3K180166Life Spine Lumbar Fixation System (SENTRY)Life Spine, Inc.20189—
+3K172019Brisbane ALIF Device, Gladstone ALIF DeviceSignature Orthopaedics Pty, Ltd.20170—
+3K130868Nuvasive Decade Lateral Plate SystemNuvasive, Inc.201319—
+3K121837Nuvasive Brigade Anterior Plate SystemNuvasive, Inc.20123—
+3K091044Spinal Usa Anterior Lumbar Plate SystemSpinal USA2009159—
+4K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+4K260340HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC…HC Biologics, LLC20260—
+4K260015ANTERIS Thoracolumbar Plate SystemSpineCraft20260—
+4K253201Lumbar Spine Truss System - Plating Solution (LSTS-PS)4Web, Inc.20260—
+4K252711Advantage-C™ Ti3D Cervical Interbody Fusion DeviceIntelivation Technologies20260—
+4K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc.20250—
+4K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+4K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc.20250—
+4K241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc.20241—
+4K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+4K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc.20241—
+4K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+4K231739Cervical Spine Truss System (CSTS)4Web Medical, Inc.20232—
+4K222988neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D CervicalHt Medical D.B.A. Xenix Medical20232—
+4K230851Kodiak Lumbar Spacer SystemMet One Technologies, LLC20230—
+4K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+4K230424Omnia Medical Coupler-A™ Anterior Lumbar Plate System; Omnia Medical Coupler-L™ Lateral…Omnia Medical, LLC20230—
+4K223362Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device4Web Medical, Inc.20233—
+4K222628Life Spine ALIF Buttress Plate SystemLife Spine, Inc.20220—
+4K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+4K220478NuVasive MOD-EX XLIF Interbody System, NuVasive MOD-EX XLIF Plated 2.0 Interbody SystemNu Vasive, Incorporated20222—
+4K212527Cervical Spine Truss System Plating Solution (CSTS-PS)4Web Medical, Inc.20220—
+4K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+4K211474Kleiner KG2 SystemBAAT Medical Products B.V.20210—
+4K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+4K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+4K202495SIRION Lateral Lumbar Interbody FusionAstura Medical, LLC20216—
+4K202305Zavation IBF SystemZavation Medical Products, LLC20209—
+4K200956NuVasive Thoracolumbar PlatesNu Vasive, Incorporated20200—
+4K200338ProLift Lateral FixatedLife Spine, Inc.20205—
+4K192006SIRION Lateral Lumbar Interbody SystemAstura Medical, LLC202014—
+4K182987Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20199—
+4K191311ATEC Lateral Interbody SystemAlphatec Spine, Inc.201978—
+4K183092Kuros TLIF CageKuros Biosciences B.V20190—
+4K183705IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc.201999—
+4K143065NuVasive ALIF Buttress Plate SystemNu Vasive, Incorporated20151—
+4K142699LITe Plate SystemStryker Corporation201446—
+4K121323Medicrea International Anterior Lumbar PlateMedicrea International20120—
+4K101255Alphatec Spine Anterior Lumbar Plating SystemAlphatec Spine, Inc.2010113—
+5K261810Vertiwedge® Intraosseous SystemFoundation Surgical Group20260—
+5K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+5K261309Palisades™ Buttress Plate SystemBethesda Medical Devices, LLC20260—
+5K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+5K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+5K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine20260—
+5K252432Flex-Z™ Cervical CageSpinepoint, LLC20260—
+5K253583LUX Expandable Lumbar Interbody SystemXenix Medical20260—
+5K253748Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer SystemLife Spine, Inc.20260—
+5K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+5K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+5K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+5K251117Cervical Spine Truss System (CSTS)4Web Medical20250—
+5K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—