510(k) Report

Devices descending from K040536

1,150 later devices reach Modification to Verte-Stack Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K151756Sterispine LC CageSafe Orthopaedics20150—
+4K150321EVOS Lumbar Interbody SystemCutting Edge Spine, LLC201592—
+4K150135DIVERGENCE-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc.2015228—
+4K142277Juliet POSpineart2014119—
+4K140864Veloxtm Interbody Fusion SystemU&I Corp.20149—
+4K140474Juliet OLSpineart2014120—
+4K133205Capstone PTC Spinal System, Clydesdale PTC Spinal SystemMedtronic Sofamor Danek USA, Inc.2014124—
+4K132926Velofixtm Interbody Fusion SystemU&I Corp.201410—
+4K133557Juliet LL Lateral Lumbar CageSpineart2014147—
+4K123758Tasmin RSignus Medizintechnik GmbH20141—
+4K133645Perimeter C Spinal System, Capstone Spinal System, Capstone L Spinal System, Perimeter…Medtronic Sofamor Danek USA, Inc.20146—
+4K133650Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.2013344—
+4K132897Clydesdale Spinal SystemMedtronic Sofamor Danek, Inc.2013279—
+4K123027Capstone (R) Spinal SystemMedtronic Sofamor Danek, Inc.2013709—
+4K121982Sovereign Spinal SystemMedtronic Sofamor Danek2012155—
+4K121683Acculif TL CageCoalign Innovations, Inc.2012682—
+4K112444Anatomic Peek Cervical Fusion SystemMedtronic Sofamor Danck USA, Inc.2011324—
+4K091883T2 Spinal SystemMedtronic Sofamor Danek USA, Inc.200951—
+4K082732Modification to: Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.2008710—
+4K073285Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek USA, Inc.2008637—
+4K071033T2 XVBR Spinal SystemMedtronic Sofamor Danek200750—
+4K062427Verte-Stack Spinal SystemMedtronic Sofamor Danek2006151—
+5K261049Scala® TLSpineart SA20260—
+5K261408SABER-XA SystemElevation Spine20260—
+5K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+5K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+5K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+5K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+5K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+5K250773Luna® Ti Interbody Fusion SystemSpinal Elements, Inc.20260—
+5K253577IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)Medicrea International S.A.S. (Medtronic)20250—
+5K252351UniSpace® TPLIF CageCg Medtech Co., Ltd.20250—
+5K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+5K253331PressON Spinal Fixation SystemNexus Spine20250—
+5K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+5K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+5K242267Gemini Medical Cage SystemZheJiang Decans Medical Devices Co., Ltd.20241—
+5K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+5K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc.20241—
+5K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+5K241438Signus Tetris™ St; Signus Tetris™ R StSignus Medizintechnik GmbH20240—
+5K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+5K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+5K240368E3D™-A Interbody SystemEvolution Spine20247—
+5K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+5K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+5K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+5K233839Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT…Gbs Commonwealth Co., Ltd.20231—
+5K233414Shoreline ACS Interbody System; Shoreline RT Interbody SystemSeaSpine Orthopedics Corporation20238—
+5K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+5K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+5K222874CarboClear Cervical Cage System, CarboClear Cervical VBR SystemCarbofix Orthpedics, Ltd.20230—
+5K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+5K230329F3D Interbody SystemCorelink, LLC20230—
+5K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+5K221447Southern Anterior Screw Fixated Cage (SASCA)Southern Medical (Pty), Ltd.20220—
+5K221858ZSFab Lumbar Interbody SystemZsfab, Inc.20224—
+5K221172FOCUS Interbody SystemOc Medical Devices20220—
+5K222383Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX Stealth (TM)…Medtronic Sofamor Danek USA, Inc.20220—
+5K220523restor3d TiDAL Lumbar Interbody Fusion DeviceRestor3D20222—
+5K221180Anteralign (TM) Spinal System with Titan NanoLOCK Surface Technology Navigated InstrumentsMedtronic Sofamor Danek USA, Inc.20222—
+5K220711SeaSpine Meridian System, SeaSpine Meridian Anterior Plate SystemSeaSpine Orthopedics Corporation202210—
+5K212653Catalyft LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.202127
+5K211769OneLIF Intervertebral Body Replacement SystemNovapproach Spine202112
+5K210470C-CURVE Interbody Fusion DeviceMedicrea International SA20210—
+5K210583SeaSpine WaveForm™ A Interbody SystemSeaSpine Orthopedics Corporation202114—
+5K201939GAIA Lumbar Interbody Fusion Device (LIFD) FamilyPrinterprezz20200—
+5K202190Oculus-SA Lumbar Cage SystemNeurostructures20200—
+5K200541Hive™ Stand-alone Anterior Lumbar Interbody SystemHd Lifesciences, LLC20201—
+5K192492EL CAPITAN Anterior Lumber Interbody SystemAstura Medical, LLC202010—
+5K200312Tryptik TiSpineart20202—
+5K200552EVOS Lumbar Interbody SystemCutting Edge Spine, LLC20200—
+5K192115SABLE Expandable SpacerGlobus Medical, Inc.202037—
+5K182987Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20199—
+5K191134IB3D AlifMedicrea International SA20191—
+5K191066CD Horizon™ Astute™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201921—
+5K191391HEDRON Lumbar SpacersGlobus Medical, Inc.201984—
+5K191039Navigated T2 STRATOSPHERE Inserters and Navigated TemplatesMedtronic Sofamor Danek USA, Inc.201918—
+5K192018Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic…Titan Spine, Inc.20191024
+5K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+5K182158UNiD Patient-matched PLIF cageMedicrea International SA201921—
+5K183243Velofix TLIF CageU&I Corporation20190—
+5K190092UNiD Patient specific 3D printed TLIF cageMedicrea International SA201913—
+5K183197PYRAMESH™ Implant SystemMedtronic Sofamor Danek USA, Inc.20190—
+5K180230NEST Interbody SystemPaonan Biotech Co., Ltd.20191—
+5K183510T2 STRATOSPHERE Expandable Corpectomy SystemMedtronic Sofamor Danek USA, Inc.201927—
+5K181899Roccia® PlifSilony Medical GmbH20180—
+5K182470Plateau Spacer SystemLife Spine20180—
+5K181818Scarlet AL-TSpineart201864—
+5K181203Juliet TiSpineart20181—
+5K180674EVOL® ha-C Cervical Interbody Fusion SystemCutting Edge Spine, LLC20183—
+5K173189Lumfuse TPPrecifit Medical, Ltd.20180—
+5K172568CervagePrecifit Medical, Ltd.20181—
+5K180891EVOL Spinal Interbody System, EVOS Lumbar Interbody SystemCutting Edge Spine, LLC20181—
+5K180071STYLO Interbody Fusion DeviceLegend Spine Technologies20180—
+5K173782UNiD Patient Specific 3D printed cageMedicrea International SA201823—
+5K172947HALF DOME Posterior Lumbar Interbody SystemAstura Medical201822—
+5K172816TiGer Shark™ SystemChoicespine, LP201859—
+5K173702Juliet Ti LLSpineart20182—
+5K171848FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO…Globus Medical, Inc.201755—