510(k) Report

Devices descending from K080646

193 later devices reach C-Tek Maxan Anterior Cervical Plate System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K250446Frida™ Anterior Cervical Plate SystemSpineup, Inc.20250—
+1K213456Xenco Medical Multilevel CerviKitXenco Medical, LLC20210—
+1K192494NexGen Anterior Cervical Plate SystemPrecision Spine20190—
+1K191786Cyclops™ Anterior Cervical Plate SystemDegen Medical, Inc.20191—
+1K160702ZION Anterior Cervical Fixation SystemAstura Medical20163—
+1K151553Anterior Cervical Plate SystemOsteomed Implantes, Ltda201611—
+1K150666uNion Cervical Plate SystemUlrich Medical USA201531
+1K133518Maxan Anterior Cervical Plate SystemBiomet Spine (Aka Ebi, LLC)2014251
+1K131521Velox Anterior Cervical Plate SystemSpinecraft, LLC20130—
+1K133475Struxxure Anterior Cervical Plate and ScrewsNexxt Spine, LLC2013132—
+1K081038Atlantis Anterior Cervical Plate SystemMedtronic Sofamor Danek2008353
+2K240690STRUXXURE® MCS Anterior Cervical Plate SystemNexxt Spine20244—
+2K240515uNion® MAX Cervical Plate SystemUlrich Medical USA, Inc.20240—
+2K221053Magnes-C Anterior Cervical Plate SystemFellowship of Orthopaedic Researchers, Inc.20230—
+2K213901Cyclops™ Anterior Cervical Plate SystemDegen Medical20220—
+2K210424Quantum Anterior Cervical PlateNvision Biomedical Technologies, Inc.20214—
+2K210325APOLLO Anterior Cervical Plate (ACP) SystemAurora Spine, Inc.20210—
+2K202227Artus™ cervical plate systemUlrich GmbH & Co. KG20200—
+2K201979Cervical Plate SystemEminent Spine, LLC20201—
+2K200927Transept Cervical Plate SystemNeurostructures, Inc.20200—
+2K201029Sapphire® Spinal System, Sapphire X Anterior Cervical Plate Spinal SystemSpinal Elements, Inc.20201—
+2K200995Insignia™ Anterior Cervical Plate SystemAlphatec Spine, Inc.2020729
+2K182885Atlantis™ Anterior Cervical Plate, Divergence™ Anterior Cervical Fusion System, Premier™…Medtronic Sofamor Danek USA, Inc.20198—
+2K173306EZ PlateZavation Medical Products, LLC20180—
+2K172585Liberty Anterior Cervical PlateValorus Spine20170—
+2K163104Terrace™ Anterior Cervical Plate SystemCorelink, LLC201718—
+2K162638CETRA Anterior Cervical Plate SystemOrthofix, Inc.20163—
+2K162194MEDICREA INTERNATIONAL Anterior Cervical Locking Plate SystemMedicrea International SA20160—
+2K162250FortiBridge Anterior Cervical Plate SystemNanovis Spine, LLC20160—
+2K161524Tangis Anterior Cervical PlateNvision Biomedical Technologies, LLC20168—
+2K150700ACP 1 Anterior Cervical Plating SystemStryker Corporation20150—
+2K141632Zevo (TM) Anterior Cervical Plate SystemMedtronic Sofamor Danek USA, Inc.2014181
+2K141376Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx, Struxxure Anterior…Nexxt Spine, LLC2014106—
+2K140361Meta-C Cervical PlateMedacta International20140—
+2K131512Katia SystemShanghai Sanyou Medical Co, Ltd.20131—
+2K130640Atlantis Anterior Cervical Plate SystemMedtronic Sofamor Danek USA, Inc.201332—
+3K252776ARIES Anterior Cervical Plate SystemsZheJiang Decans Medical Devices Co., Ltd.20260—
+3K252611aprevo® cervical plating systemCarlsmed, Inc.20253—
+3K240935ARENAL Anterior Cervical Plate SystemEffortmed, LLC20240—
+3K232605Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue®…Lesspine Innovations20230—
+3K231593Sapphire X3 Anterior Cervical Plate SystemSpinal Elements, Inc.20230—
+3K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+3K231090Zevo Anterior Cervical Plate SystemMedtronic Sofamor Danek USA, Inc.20231—
+3K231145Axis Anterior Cervical Plate SystemSouthern Medical (Pty), Ltd.20230—
+3K223753Cervical Plate SystemDouble Medical Technology, Inc.20230—
+3K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+3K2117123° Anterior Cervical Plating System, Reliant Anterior Cervical Plating System, Unity…Orthofix US, LLC20220—
+3K213443Insignia™ Anterior Cervical Plate SystemAlphatec Spine, Inc.20216—
+3K202657Javelin Tailor's Bunion Fixation SystemNvision Biomedical Technologies, Inc.20201—
+3K193494Origin™ Anterior Cervical Plate SystemOrthopaedic & Spine Development20200—
+3K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+3K192314RESONATE Anterior Cervical Plate SystemGlobus Medical, Inc.20193—
+3K191584FORTICO Anterior Cervical Fixation SystemCamber Spine Technologies, LLC20192—
+3K190016Lateral Plate SystemCorelink, LLC201915—
+3K181190Pinehurst Anterior Cervical Plate SystemSignature Orthopaedics Pty, Ltd.20190—
+3K1824894CIS® Pinehurst Anterior Cervical Plate systemSolco Biomedical Co., Ltd.20191—
+3K181435ATEC Cervical Spacer SystemAlphatec Spine, Inc.2018100—
+3K173091Boundary Anterior Lumbar Buttress PlateNvision Biomedical Technologies, LLC20170—
+3K163366Shanghai Sanyou CARMEN Cervical Fusion SystemShanghai Sanyou Medical Co, Ltd.20170—
+3K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+3K152623ATLANTIS Anterior Cervical Plate SystemMedtronic Sofamor Danek USA, Inc.20159—
+3K143706FortiBridge Anterior Cervical Plate SystemNanovis Spine, LLC20151—
+3K141599Divergence Anterior Cervical Fusion SystemMedtronic Sofamor Danek USA, Inc.201516—
+3K140417Divergence Mini-Plate Anterior Cervical Fusion SystemMedtronic Sofamor Danek, Inc.201411—
+4K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+4K260570corra™ cervical plating systemCarlsmed, Inc.20261—
+4K260291Vortex5 Tailor's Bunion Correction SystemNvision Biomedical Technologies, Inc.20260—
+4K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+4K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+4K241164IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic)202412
+4K242069Eminent Spine Scoliosis Deformity Pedicle Screw SystemEminent Spine20240—
+4K231251FlexWing Anterior Cervical Plate SystemJeil Medical Corporation20242—
+4K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+4K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+4K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+4K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+4K223321Omnia Medical Coupler-C Anterior Cervical PlateOmnia Medical, LLC20230—
+4K212358Romero Cervical CageSpineup, Inc.20226—
+4K211805IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec…Alphatec Spine, Inc.202138—
+4K211205Prase-C Anterior Cervical Plate SystemGbs Commonwealth Co., Ltd.20210—
+4K203065Lumbar Spine Truss System Plating Solution (LSTS-PS)4Web, Inc.20219—
+4K202192STRUXXURE®-L and STRUXXURE®-A Plate SystemNexxt Spine, LLC20200—
+4K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+4K183705IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc.201999—
+4K142450DIVERGENCE Anterior Cervical Fusion SystemMedtronic Sofamor Danek USA, Inc.20146—
+5K262149corra® cervical plating systemCarlsmed, Inc.20260—
+5K252432Flex-Z™ Cervical CageSpinepoint, LLC20260—
+5K253201Lumbar Spine Truss System - Plating Solution (LSTS-PS)4Web, Inc.20260—
+5K260038E3D™-C Interbody SystemEvolution Spine20261—
+5K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+5K253577IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)Medicrea International S.A.S. (Medtronic)20250—
+5K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc.20250—
+5K252826ARIX Femur Nail SystemJeil Medical Corporation20250—
+5K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+5K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc.20241—
+5K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+5K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical20244—
+5K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+5K230639Align Cervical Interbody Fusion SystemAcuity Surgical Devices, LLC20232—
+5K231739Cervical Spine Truss System (CSTS)4Web Medical, Inc.20232—