510(k) Report

Devices descending from K031914

1,530 later devices reach Spinal Concepts, Inc. Cadence and Fortitude through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K210583SeaSpine WaveForm™ A Interbody SystemSeaSpine Orthopedics Corporation202114—
+7K210439NuVasive MOD-EX XLIF Interbody SystemNu Vasive, Incorporated20214—
+7K203311ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20213—
+7K200919Idys ALIF 3DTiClariance20210—
+7K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc.202135—
+7K203327VERTACONNECT TLIF CageSignus Medizintechnik20210—
+7K203683CarboClear Lumbar Cage SystemCarbofix Orthpedics, Ltd.20211—
+7K203201NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated202194—
+7K203129NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) SystemPrecision Spine, Inc.20210—
+7K202495SIRION Lateral Lumbar Interbody FusionAstura Medical, LLC20216—
+7K203561ChoiceSpine Navigation SystemChoice Spine, LLC20211—
+7K200458Tailored-C Cervical Interbody Fusion SystemBespoke Technologies20203—
+7K202820Australis Anterior Lumbar Cage SystemPrism Surgical Designs Pty, Ltd.20200—
+7K202298Lucent XP, Lucent XP CurvedSpinal Elements, Inc.20202—
+7K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc.202067—
+7K201755WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody SystemSeaSpine Orthopedics Corporation202017—
+7K201692NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated202067—
+7K201453Fortilink Cages with TiPlus TechnologyParadigm Spine GmbH20204—
+7K200953NuVasive® Cohere® Thoracolumbar Interbody SystemNu Vasive, Incorporated2020141—
+7K202190Oculus-SA Lumbar Cage SystemNeurostructures20200—
+7K201820NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated2020156—
+7K200115Cavetto-SA Cervical Cage SystemNeurostructures, Inc.202019—
+7K201367FlareHawk TiHawk9 Interbody Fusion SystemIntegrity Implants, Inc.20202—
+7K201506Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical…Meditech Spine, LLC20200—
+7K201721TruLift Expandable Spacer SystemLife Spine, Inc.20205—
+7K200592GS Medical AnyPlus PEEK Cage SystemGS Medical Co., Ltd.20206—
+7K200920Idys ALIF ZP 3DTiClariance, Sas20203—
+7K200352Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20202—
+7K200991EVOL Spinal Interbody SystemCutting Edge Spine, LLC20200—
+7K193457AUDERE Lumbar Spacer SystemMet One Technologies20201—
+7K200541Hive™ Stand-alone Anterior Lumbar Interbody SystemHd Lifesciences, LLC20201—
+7K193153SPIRA-C Integrated Fixation SystemCamber Spine Technologies20202—
+7K192492EL CAPITAN Anterior Lumber Interbody SystemAstura Medical, LLC202010—
+7K200312Tryptik TiSpineart20202—
+7K192006SIRION Lateral Lumbar Interbody SystemAstura Medical, LLC202014—
+7K193541NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2020157—
+7K193593NuVasive 3DP Interfixated ALIF SystemNu Vasive, Incorporated2020157—
+7K193378CarboClear Lumbar Cage SystemCarboFix Orthopedics, Ltd.20202—
+7K192993Scarlet AL-TSpineart20201—
+7K192115SABLE Expandable SpacerGlobus Medical, Inc.202037—
+7K193645nva, nvp, and nvtNvision Biomedical Technologies, Inc.20203—
+7K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine20207—
+7K192497EVOL ha - D Lateral Interbody Fusion SystemCutting Edge Spine, LLC20201—
+7K192718Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D TechnologyPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20195—
+7K1920444CIS Marlin PEEK ACIF CageSolco Biomedical Co., Ltd.20190—
+7K191834Stand-Alone ALIF Titanium SystemLife Spine, Inc.20190—
+7K193174Keos Lumbar IBFDKeos20190—
+7K192248Cortina™ [MAX] Lumbar Cage SystemNeurostructures, Inc.20190—
+7K192336Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.201917—
+7K190721LongBow TiLife Spine, Inc.20190—
+7K192168Idys ALIF ZP 3DTiClariance, Sas20195—
+7K192117Small VBR™Ulrich GmbH & Co. KG20196—
+7K191134IB3D AlifMedicrea International SA20191—
+7K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+7K1803473d CageFims Co., Ltd.20190—
+7K192760NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2019163—
+7K191066CD Horizon™ Astute™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201921—
+7K191354Ti3Z Cervical Interbody SystemZavation Medical Products, LLC201913—
+7K183407Triton CageMedyssey USA, Inc.20190—
+7K192054Endoskeleton TAS PlateTitan Spine, Inc.20190—
+7K192047Rampart™ One Lumbar Interbody Fusion SystemSpineology, Inc.20190—
+7K192018Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic…Titan Spine, Inc.20191024
+7K191565Endoskeleton TCS Interbody Fusion DeviceTitan Spine, Inc.201901
+7K183249Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved…Stryker Spine20196—
+7K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+7K182158UNiD Patient-matched PLIF cageMedicrea International SA201921—
+7K183243Velofix TLIF CageU&I Corporation20190—
+7K190498Fortilink® IBF System with TETRAfuse®3D Technology, include the following designs…Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20197—
+7K183064TxTi IBF SystemInnovasis, Inc.2019481
+7K182139AXTi Titanium Stand-Alone ALIF SystemInnovasis, Inc.201972—
+7K191263Idys ALIF TiVacClariance, Sas20190—
+7K190877Juliet® Ti LL Lumbar Interbody DeviceSpineart201911
+7K190092UNiD Patient specific 3D printed TLIF cageMedicrea International SA201913—
+7K182877HALF DOME Posterior Lumbar Interbody SystemAstura Medical, LLC201921—
+7K182920MiRus™ Lumbar Interbody Fusion System consisting of CALLISTO™ PEEK Posterior Lumbar…MiRus, LLC20199—
+7K183092Kuros TLIF CageKuros Biosciences B.V20190—
+7K190055Duo Lumbar Interbody Fusion DeviceSpineology, Inc.20191—
+7K183397ChoiceSpine Stealth Cervical Spacer SystemChoicespine, LP201916—
+7K183705IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc.201999—
+7K183588Choice Spine Hawkeye Vertebral Body Replacement (VBR) SystemChoicespine20195—
+7K183083Shoreline Cervical Interbody RT SystemSeaSpine Orthopedics Corporation201960—
+7K183557Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device…Titan Spine, Inc.20191043
+7K182284Tyber Medical PT Interbody SpacerTyber Medical, LLC20195—
+7K181096Avenue P Cage SystemZimmer Biomet Spine, Inc.20190—
+7K182721Choice Spine Navigation SystemChoicespine, LP20192—
+7K181589Curiteva Lumbar Interbody Fusion SystemCuriteva, LLC20186—
+7K183239CoreLink F3D™ Lateral SystemCorelink, LLC20188—
+7K182007Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies20180—
+7K181357PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc.201897—
+7K180665SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage SystemK2m, LLC20189—
+7K181921Solidity Vertebral Body ReplacementUlrich Medical USA20182—
+7K181829Velofix TLIF CageU&I Corporation20181—
+7K182195Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20183—
+7K181621Stable-C Interbody SystemNexus Spine, LLC20187—
+7K181644EIT Cellular Titanium® Lumbar Cage LLIFEit Emerging Implant Technologies GmbH2018141—
+7K181818Scarlet AL-TSpineart201864—
+7K181531SpineEX Sagittae Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20183—
+7K181860NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2018159—
+7K181591Fixated Asfora BULLET CAGE® (FABC)Medical Designs, LLC20180—
+7K181702Tranquil-L Interbody SystemNexus Spine, LLC20188—