510(k) Report

Devices descending from K042268

1,620 later devices reach Ebi Cas Spine Spacer System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K240715Idys® C ZP 3DTiClariance20240—
+4K233375Tranquil-L Interbody SystemNexus Spine, LLC20240—
+4K240416Tranquil-C Interbody SystemNexus Spine, LLC20243—
+4K232432E3D™-A Interbody SystemEvolution Spine20248—
+4K231715MONDRIAN™ Anterior Lumbar Plate SystemCtl Medical Corporation20240—
+4K233594Genesys Spine 3DP AIS-C II Cervical Interbody SystemGenesys Spine20232—
+4K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+4K231836ClariVy™ Cervical IBF SystemVy Spine, LLC20232—
+4K231704Pro-Link® & Pro-Link® Ti Barbs Cervical Spacer SystemLife Spine, Inc.20230—
+4K231763Stable-C Interbody SystemNexus Spine, LLC20236—
+4K230607SPICCA Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+4K222874CarboClear Cervical Cage System, CarboClear Cervical VBR SystemCarbofix Orthpedics, Ltd.20230—
+4K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+4K220513NITRO Interbody Fusion Cage System FamilyCtl Medical Corporation20230—
+4K230808PEEK SA Anterior Lumbar Interbody Fusion (ALIF) SystemKyocera Medical Technologies, Inc.20230—
+4K230026SqualeImplanet, S.A.20230—
+4K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+4K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+4K220296Manta Ray TDF SpacerSeaSpine Orthopedics Corporation20231—
+4K223731NuVasive Modulus-C Interbody SystemNuvasive, Inc.202311—
+4K222806Kodiak C Spinal Implant SystemMet One Technologies, LLC20221—
+4K222009aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.202212—
+4K221545MectaLIF Anterior ExtensionMedacta International S.A.202226
+4K222082aprevo® anterior and lateral lumbar interbody fusion devices, aprevo® transforaminal…Carlsmed, Inc.202211—
+4K220096Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20220—
+4K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+4K212853Cervical Stand-Alone SystemEminent Spine, LLC202118—
+4K212389Advantage Lumbar System - ALIF, PLIF, DLIF, TLIFIntelivation, LLC20210—
+4K212562Idys-C ZP 3DTiClariance, SA20211—
+4K211501Advantage-C PEEK Cervical lnterbody Fusion DeviceLntelivation, LLC20211—
+4K210521DEXA-C Cervical Interbody SystemAurora Spine, Inc.20210—
+4K210382Blustone Synergy Diamond SA Cervical SystemBlustone Synergy, LLC20210—
+4K210542aprevo Transforaminal IBFCarlsmed, Inc.202112—
+4K210214NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody SystemNu Vasive, Incorporated20213—
+4K203520Blustone Synergy Interbody Fusion SystemBlustone Synergy, LLC20210—
+4K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+4K203129NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) SystemPrecision Spine, Inc.20210—
+4K201643ChoiceSpine Tiger Shark Cervical Spacer SystemChoice Spine, LLC20204—
+4K193000Hexanium® ACIFSpinevision, S.A.S.202014—
+4K202305Zavation IBF SystemZavation Medical Products, LLC20209—
+4K201769Cavetto [MAX] Cervical Cage SystemNeurostructures, Inc.20200—
+4K192863MONDRIAN Lumbar Interbody Fusion Cage SystemCtl Medical Corporation20203—
+4K201500Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar SpacerLife Spine, Inc.20203—
+4K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC202025—
+4K193153SPIRA-C Integrated Fixation SystemCamber Spine Technologies20202—
+4K193541NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2020157—
+4K200543NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) SystemNexxt Spine, LLC202072—
+4K192906Mecta-C Stand AloneMedacta International S.A.20201—
+4K193412NEXXT MATRIXX SystemNexxt Spine, LLC20201—
+4K193320KMTI Tesera SA Anterior Lumbar Interbody Fusion (ALIF) SystemKyocera Medical Technologies, Inc.20203—
+4K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+4K193645nva, nvp, and nvtNvision Biomedical Technologies, Inc.20203—
+4K193359SureMAX Family of Cervical SpacersAdditive Implants, Inc.202014—
+4K192718Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D TechnologyPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20195—
+4K1803473d CageFims Co., Ltd.20190—
+4K190426ALTA Anterior Cervical Corpectomy SystemAstura Medical, LLC20193—
+4K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer…Choice Spine, LLC20194—
+4K190870Cervical Spinal Truss System-Stand Alone (CSTS-SA)4Web, Inc.201910—
+4K191565Endoskeleton TCS Interbody Fusion DeviceTitan Spine, Inc.201901
+4K190498Fortilink® IBF System with TETRAfuse®3D Technology, include the following designs…Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20197—
+4K190618RIGEL PEEK Anterior Cervical Interbody Fusion SystemMiRus, LLC20191—
+4K190380nvcNvision Biomedical Technologies, Inc.20193—
+4K183083Shoreline Cervical Interbody RT SystemSeaSpine Orthopedics Corporation201960—
+4K182210TiWAVE-L Porous Titanium Lumbar CageKalitec Medical, LLC20193—
+4K183239CoreLink F3D™ Lateral SystemCorelink, LLC20188—
+4K182746ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc.2018110—
+4K181590Neurostructures Cavetto® [MAX] Cervical Cage SystemNeurostructures, Inc.20180—
+4K181621Stable-C Interbody SystemNexus Spine, LLC20187—
+4K181860NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2018159—
+4K181397DualXInnovasive, Inc.201815—
+4K181702Tranquil-L Interbody SystemNexus Spine, LLC20188—
+4K181229TirboLOX-C Cervical IBFDCaptiva Spine, Inc.20180—
+4K181337Sypher Spacer SystemBiogennix, LLC20180—
+4K181655Renovis S180 Lateral Lumbar Interbody Fusion SystemRenovis Surgical Technologies20184—
+4K181483Tranquil Interbody SystemNexus Spine, LLC20186—
+4K181347Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC201824—
+4K180814CoreLink® M3™ Stand-Alone Anterior Lumbar SystemCorelink, LLC201818—
+4K180076Ti 3Z Interbody SystemZavation Medical Products, LLC20184—
+4K180556Corelink Foundation 3D Anterior Lumbar SystemCorelink, LLC20185—
+4K181030Rubicon Lumbar Interbody Fusion SystemRubicon Spine, LLC20180—
+4K180695FBC 921 (Alif)Fbc Device Aps20180—
+4K181246Zavation IBF SystemZavation Medical Products, LLC201822—
+4K172788MONET™ Anterior Cervical Interbody Fusion Cage SystemCtl Medical Corporation20181—
+4K180674EVOL® ha-C Cervical Interbody Fusion SystemCutting Edge Spine, LLC20183—
+4K180502S128 Anterior Lumbar Interbody Fusion (ALIF) SystemRenovis Surgical Technologies, Inc.201811—
+4K173787X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage System…Medos International SARL20182—
+4K172480icotec Interbody Cage SystemIcotec AG20185—
+4K172484A-CIFT SoloFuseSpinefrontier, Inc.201871
+4K173082Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20185—
+4K173324ALTA Anterior Cervical Interbody SpacerAstura Medical201827—
+4K173077Cavetto-SA Cervical Cage SystemNeurostructures, Inc.201821—
+4K171312FortiCore®Nanovis, LLC20183—
+4K172212MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEK™Ctl Medical Corporation20181—
+4K172926SeaSpine Vu cPOD, Zuma-C, Complete CervicalSeaSpine Orthopedics Corporation201761—
+4K173182ProLift® Expandable SystemLife Spine, Inc.201737—
+4K172676NuVasive® Modulus-C Interbody SystemNu Vasive, Incorporated2017125—
+4K172009Cascadia Interbody SystemK2m, Inc.2017433
+4K172419Velofix™ TLIF CageU&I Corporation20172—
+4K170235Lucent®Spinal Elements, Inc.2017107—
+4K172424Velofix™ SA Cervical CageU&I Corporation201751