510(k) Report

Devices descending from K040482

1,621 later devices reach Ebi Esl Spine Spacer System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K253213SAGI Cervical Cage SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+5K253260ORIO-3D Cage SystemSpineCraft20260—
+5K252219Cervical Interbody and VBR Fusion SystemSync Surgical20260—
+5K252711Advantage-C™ Ti3D Cervical Interbody Fusion DeviceIntelivation Technologies20260—
+5K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+5K243074Spectrum Spine Lumbar Cage SystemSpectrum Spine, Inc.20252—
+5K242483Genesys Spine AIS-C II Cervical Interbody Fusion SystemGenesys Spine20250—
+5K2316554CIS® Chiron Spinal Fixation SystemSolco Biomedical Co., Ltd.20240—
+5K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+5K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+5K241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc.20241—
+5K233807LumiVy™ Lumbar IBF SystemVy Spine, LLC20241—
+5K241605Adaptix™ PEEK Interbody System with Nanotechnology; Capstone Control™ PEEK Spinal System…Nanovis, LLC20240—
+5K241846E3D™-C Interbody SystemEvolution Spine20246—
+5K241019aprevo® TLIF-C Articulating SystemCarlsmed20244—
+5K240368E3D™-A Interbody SystemEvolution Spine20247—
+5K240715Idys® C ZP 3DTiClariance20240—
+5K240416Tranquil-C Interbody SystemNexus Spine, LLC20243—
+5K232432E3D™-A Interbody SystemEvolution Spine20248—
+5K231715MONDRIAN™ Anterior Lumbar Plate SystemCtl Medical Corporation20240—
+5K233594Genesys Spine 3DP AIS-C II Cervical Interbody SystemGenesys Spine20232—
+5K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+5K231836ClariVy™ Cervical IBF SystemVy Spine, LLC20232—
+5K231704Pro-Link® & Pro-Link® Ti Barbs Cervical Spacer SystemLife Spine, Inc.20230—
+5K231076VariLift®-C Interbody Fusion SystemWenzel Spine, Inc.20234—
+5K232154MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate FixationMiRus, LLC20230—
+5K231763Stable-C Interbody SystemNexus Spine, LLC20236—
+5K222874CarboClear Cervical Cage System, CarboClear Cervical VBR SystemCarbofix Orthpedics, Ltd.20230—
+5K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+5K220513NITRO Interbody Fusion Cage System FamilyCtl Medical Corporation20230—
+5K230808PEEK SA Anterior Lumbar Interbody Fusion (ALIF) SystemKyocera Medical Technologies, Inc.20230—
+5K230026SqualeImplanet, S.A.20230—
+5K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+5K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+5K220296Manta Ray TDF SpacerSeaSpine Orthopedics Corporation20231—
+5K223731NuVasive Modulus-C Interbody SystemNuvasive, Inc.202311—
+5K222806Kodiak C Spinal Implant SystemMet One Technologies, LLC20221—
+5K222009aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.202212—
+5K221545MectaLIF Anterior ExtensionMedacta International S.A.202226
+5K222082aprevo® anterior and lateral lumbar interbody fusion devices, aprevo® transforaminal…Carlsmed, Inc.202211—
+5K220523restor3d TiDAL Lumbar Interbody Fusion DeviceRestor3D20222—
+5K220115ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion SystemMiRus, LLC20220—
+5K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC20223—
+5K213355Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20224—
+5K220453FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20221—
+5K220096Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20220—
+5K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+5K212853Cervical Stand-Alone SystemEminent Spine, LLC202118—
+5K212389Advantage Lumbar System - ALIF, PLIF, DLIF, TLIFIntelivation, LLC20210—
+5K212562Idys-C ZP 3DTiClariance, SA20211—
+5K211501Advantage-C PEEK Cervical lnterbody Fusion DeviceLntelivation, LLC20211—
+5K211388Lateral Spine Truss System (LSTS) Interbody Fusion Device4Web Medical, Inc.20210—
+5K210521DEXA-C Cervical Interbody SystemAurora Spine, Inc.20210—
+5K210382Blustone Synergy Diamond SA Cervical SystemBlustone Synergy, LLC20210—
+5K210542aprevo Transforaminal IBFCarlsmed, Inc.202112—
+5K210595SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar SpacersCamber Spine Technologies, LLC20213—
+5K210214NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody SystemNu Vasive, Incorporated20213—
+5K203038Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20215—
+5K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+5K203129NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) SystemPrecision Spine, Inc.20210—
+5K201643ChoiceSpine Tiger Shark Cervical Spacer SystemChoice Spine, LLC20204—
+5K202198FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20202—
+5K193000Hexanium® ACIFSpinevision, S.A.S.202014—
+5K202305Zavation IBF SystemZavation Medical Products, LLC20209—
+5K201367FlareHawk TiHawk9 Interbody Fusion SystemIntegrity Implants, Inc.20202—
+5K201769Cavetto [MAX] Cervical Cage SystemNeurostructures, Inc.20200—
+5K192863MONDRIAN Lumbar Interbody Fusion Cage SystemCtl Medical Corporation20203—
+5K201585Monterey AL Interbody SystemStryker Corporation202044
+5K201500Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar SpacerLife Spine, Inc.20203—
+5K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC202025—
+5K200685RIGEL 3DR Anterior Cervical Interbody Fusion SystemMiRus, LLC20200—
+5K193153SPIRA-C Integrated Fixation SystemCamber Spine Technologies20202—
+5K200312Tryptik TiSpineart20202—
+5K193541NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2020157—
+5K200543NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) SystemNexxt Spine, LLC202072—
+5K192906Mecta-C Stand AloneMedacta International S.A.20201—
+5K193412NEXXT MATRIXX SystemNexxt Spine, LLC20201—
+5K193320KMTI Tesera SA Anterior Lumbar Interbody Fusion (ALIF) SystemKyocera Medical Technologies, Inc.20203—
+5K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+5K193645nva, nvp, and nvtNvision Biomedical Technologies, Inc.20203—
+5K193359SureMAX Family of Cervical SpacersAdditive Implants, Inc.202014—
+5K192718Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D TechnologyPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20195—
+5K191134IB3D AlifMedicrea International SA20191—
+5K1803473d CageFims Co., Ltd.20190—
+5K190426ALTA Anterior Cervical Corpectomy SystemAstura Medical, LLC20193—
+5K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer…Choice Spine, LLC20194—
+5K190870Cervical Spinal Truss System-Stand Alone (CSTS-SA)4Web, Inc.201910—
+5K191565Endoskeleton TCS Interbody Fusion DeviceTitan Spine, Inc.201901
+5K190291Addivation Medical Cervical Interbody SystemAddivation Medical, LLC20190—
+5K190498Fortilink® IBF System with TETRAfuse®3D Technology, include the following designs…Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20197—
+5K190380nvcNvision Biomedical Technologies, Inc.20193—
+5K183083Shoreline Cervical Interbody RT SystemSeaSpine Orthopedics Corporation201960—
+5K182210TiWAVE-L Porous Titanium Lumbar CageKalitec Medical, LLC20193—
+5K183239CoreLink F3D™ Lateral SystemCorelink, LLC20188—
+5K182746ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc.2018110—
+5K181590Neurostructures Cavetto® [MAX] Cervical Cage SystemNeurostructures, Inc.20180—
+5K181621Stable-C Interbody SystemNexus Spine, LLC20187—
+5K181860NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2018159—
+5K181397DualXInnovasive, Inc.201815—
+5K181702Tranquil-L Interbody SystemNexus Spine, LLC20188—