510(k) Report

Devices descending from K093669

744 later devices reach Sec Ibf Cage through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+7K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—
+7K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+7K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+7K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+7K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+7K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+7K252742Navigated InstrumentsTyber Medical, LLC20251—
+7K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+7K253331PressON Spinal Fixation SystemNexus Spine20250—
+7K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+7K250987aprevo® posterior/transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20251—
+7K243949OsteoFlo HydroFiberSurGenTec, LLC20250—
+7K243386Ventris Intervertebral Body Fusion DeviceAcuity Surgical Devices, LLC20252—
+7K243739AxCess® Expandable Interbody SystemElliquence, LLC20250—
+7K241477aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20246—
+7K241332aprevo® anterior and lateral lumbar interbody fusion device; aprevo® anterior lumbar…Carlsmed, Inc.20245—
+7K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+7K242509HAnano InterFuse (R) Modular InterbodyNext Orthosurgical20240—
+7K241328aprevo® Anterior and Lateral Lumbar Interbody Fusion device (ALIF/LLIF); aprevo®…Carlsmed, Inc.20240—
+7K241019aprevo® TLIF-C Articulating SystemCarlsmed20244—
+7K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+7K240749PILLAR SA Ti Spacer System (82-XXX)Orthofix, Inc.202402
+7K241396uCerv Flux™-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA, Inc.20240—
+7K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+7K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+7K232282aprevo® anterior and lateral lumbar interbody fusion device, aprevo® transforaminal…Carlsmed, Inc.20240—
+7K232432E3D™-A Interbody SystemEvolution Spine20248—
+7K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+7K234087restor3d TIDAL Lumbar Interbody Fusion SystemRestor3D20240—
+7K232877FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous…K&J Consulting Corporation20231—
+7K230478Acro Composites Interbody SystemAcro Composites, LLC20230—
+7K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+7K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+7K232150ZSFab Cervical Interbody SystemZsfab, Inc.20234—
+7K230608SPICCA Stand-Alone Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+7K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+7K231140aprevo® transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20236—
+7K220261NEST-C Interbody SystemPaonan Biotech Co., Ltd.20230—
+7K221324ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF)Camber Spine Technologies20230—
+7K223326Axiom PSR SystemRestor3D202301
+7K223474PathLoc-TA Expandable Lumbar Cage SystemL&K BIOMED Co., Ltd.20231—
+7K223105Tesera-K SC SystemKyocera Medical Technologies, Inc.20225—
+7K2136534CIS Black Marlin Plif Cage System, 4CIS Dolphin Tlif Cage SystemSolco Biomedical Company India Private Limited20220—
+7K222383Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX Stealth (TM)…Medtronic Sofamor Danek USA, Inc.20220—
+7K222561AlignAcuity Surgical Devices, LLC202214—
+7K220696uCerv Flux-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA20221—
+7K221535Align Lumbar Interbody Fusion SystemAcuity Surgical Devices, LLC20223—
+7K220478NuVasive MOD-EX XLIF Interbody System, NuVasive MOD-EX XLIF Plated 2.0 Interbody SystemNu Vasive, Incorporated20222—
+7K220610SOLO-LAurora Spine, Inc.20220—
+7K212967AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.20211—
+7K211805IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec…Alphatec Spine, Inc.202138—
+7K210542aprevo Transforaminal IBFCarlsmed, Inc.202112—
+7K210439NuVasive MOD-EX XLIF Interbody SystemNu Vasive, Incorporated20214—
+7K203201NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated202194—
+7K202488ZSFab Cervical Interbody SystemZsfab, Inc.20216—
+7K201755WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody SystemSeaSpine Orthopedics Corporation202017—
+7K201692NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated202067—
+7K201820NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated2020156—
+7K200991EVOL Spinal Interbody SystemCutting Edge Spine, LLC20200—
+7K193593NuVasive 3DP Interfixated ALIF SystemNu Vasive, Incorporated2020157—
+7K193359SureMAX Family of Cervical SpacersAdditive Implants, Inc.202014—
+7K192026Peridot Intervertebral body fusion SystemGbs Commonwealth Co., Ltd.20196—
+7K192760NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2019163—
+7K192214CarboClear VBR SystemCarboFix Orthopedics, Ltd.20191—
+7K192208CORNICE Cervical Spacer SystemLegend Spine Technologies20190—
+7K191537eCarbon IBDsBack 2 Basics Direct, LLC20193—
+7K190291Addivation Medical Cervical Interbody SystemAddivation Medical, LLC20190—
+7K183243Velofix TLIF CageU&I Corporation20190—
+7K183184FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.201912—
+7K182920MiRus™ Lumbar Interbody Fusion System consisting of CALLISTO™ PEEK Posterior Lumbar…MiRus, LLC20199—
+7K182477Cervical SpacerAdditive Implants, LLC201915—
+7K180822VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion SystemWenzel Spine, Inc.20195—
+7K182284Tyber Medical PT Interbody SpacerTyber Medical, LLC20195—
+7K182210TiWAVE-L Porous Titanium Lumbar CageKalitec Medical, LLC20193—
+7K181589Curiteva Lumbar Interbody Fusion SystemCuriteva, LLC20186—
+7K181829Velofix TLIF CageU&I Corporation20181—
+7K181386NuVasive Brigade Lateral SystemNu Vasive, Incorporated2018158—
+7K181014Tritanium PL CageStryker Spine2018137—
+7K180364HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC2018106—
+7K180401TiWAVE-C™ Porous Titanium Cervical CageKalitec Direct, LLC20185—
+7K173892NuVasive® XLX Interbody SystemNu Vasive, Incorporated2018115—
+7K180891EVOL Spinal Interbody System, EVOS Lumbar Interbody SystemCutting Edge Spine, LLC20181—
+7K173082Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20185—
+7K171495Zyston Strut Open Titanium Spacer SystemZimmer Biomet Spine, Inc.20181—
+7K171312FortiCore®Nanovis, LLC20183—
+7K173159Cervical Spinal Truss System (CSTS) Interbody Fusion Device4Web, Inc.201812—
+7K172676NuVasive® Modulus-C Interbody SystemNu Vasive, Incorporated2017125—
+7K170235Lucent®Spinal Elements, Inc.2017107—
+7K172392Lateral Spinal Truss System (LSTS) Interbody Fusion Device4Web, Inc.20171—
+7K172341NuVasive® Modulus TLIF Interbody SystemNu Vasive, Incorporated2017163—
+7K172123NuVasive® Modulus XLIF Interbody SystemNu Vasive, Incorporated2017227—
+7K171689ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2017109—
+7K170119Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc.201711
+7K171633NuVasive TLX Interbody SystemNu Vasive, Incorporated2017251—
+7K171351Posterior Spine Truss System (PSTS) Interbody Fusion Device4Web, Inc.20177—
+7K171140Matrixx SystemNexxt Spine, LLC2017145—
+7K170851Anterior Spine Truss System (STS) Interbody Fusion Device4Web, Inc.20175—
+7K170318NeoFuse Ti3D PLIF/TLIF/Cervical InterbodyHt Medical, LLC201749—
+7K170399Endoskeleton TO Interbody Fusion Device (IBD)Titan Spine, LLC2017105—