510(k) Report

Devices descending from K041197

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K211441Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.20219—
+5K210214NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody SystemNu Vasive, Incorporated20213—
+5K201671A-Link ZAcuity Surgical Devices, LLC202125—
+5K200919Idys ALIF 3DTiClariance20210—
+5K202032Idys LLIF 3DTiClariance, Sas20210—
+5K200719NuVasive Navigation.S InstrumentsNu Vasive, Incorporated20204—
+5K201193SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202018—
+5K202065DOLOMITE Anterior Cervical Stabilization SystemAstura Medical, LLC20203—
+5K201073Seaspine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202017—
+5K201646Shoreline ACS (Anterior Cervical System)SeaSpine Orthopedics Corporation202020—
+5K200920Idys ALIF ZP 3DTiClariance, Sas20203—
+5K192897icotec Cervical CageIcotec AG20201—
+5K192906Mecta-C Stand AloneMedacta International S.A.20201—
+5K192168Idys ALIF ZP 3DTiClariance, Sas20195—
+5K191134IB3D AlifMedicrea International SA20191—
+5K192054Endoskeleton TAS PlateTitan Spine, Inc.20190—
+5K192018Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic…Titan Spine, Inc.20191024
+5K190885Elevation Spine Saber-C SystemElevation Spine201925—
+5K191565Endoskeleton TCS Interbody Fusion DeviceTitan Spine, Inc.201901
+5K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+5K191263Idys ALIF TiVacClariance, Sas20190—
+5K180550NuVasive Monolith Cervical Corpectomy SystemNu Vasive, Incorporated201811—
+5K180851VERTEX™ Reconstruction SystemMedtronic Sofamor Danek USA, Inc.20188—
+5K172926SeaSpine Vu cPOD, Zuma-C, Complete CervicalSeaSpine Orthopedics Corporation201761—
+5K173115COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and…Globus Medical, Inc.201783—
+5K172019Brisbane ALIF Device, Gladstone ALIF DeviceSignature Orthopaedics Pty, Ltd.20170—
+5K163375INFINITY™ OCT SystemMedtronic Sofamor Danek USA, Inc.2017165
+5K152022SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION®…Globus Medical, Inc.2017149—
+5K162327COUGAR® LS Lateral Cage System and COUGAR® SystemMedos International SARL2016111—
+5K161379ELSA SpacersGlobus Medical, Inc.2016155—
+5K160125Cascadia Interbody SystemK2m2016315—
+5K152793Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.201629—
+5K153122Endoskeleton (r) TCS SystemTitan Spine, LLC20151061
+5K151773CONCORDE Bullet Lumbar Interbody SystemMedos International SARL2015201—
+5K151596Endoskeleton TCS Interbody Fusion DeviceTitan Spine, LLC20151101
+5K142487Chesapeake Stabilization SystemK2m, Inc.201571
+5K143616AccuLIF TL and PL CageStryker Corporation20154694
+5K143214SCARLET® AC-T Secured Anterior Cervical CageSpineart20153—
+5K141896Coroent SystemNu Vasive, Incorporated2014480—
+5K141314Scarlet AC-T Secured Anterior Cervical Cage and Associated InstrumentationSpineart201438—
+5K133577Clydesdale (R) Spinal SystemMedtronic Sofamor Danek USA, Inc.2014256—
+5K133650Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.2013344—
+5K131449Coalition SpacerGlobus Medical, Inc.2013235—
+5K123656Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc.201339—
+5K121852Synthes Zero-P Variable Angle (VA)Synthes Spine Co.Lp201230—
+5K113252Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek2012306—
+5K112388Lanx Cervical SALanx, Inc.201126—
+5K110522Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc.2011106—
+5K102547Coroent Interlock SystemNuvasive, Inc.2011131—
+5K093434Vertex Reconstruction System and Vertex Select Reconstruction SystemMedtronic Sofamor Danek20097—
+5K073420Blackstone Ascent Multiaxial ScrewsBlackstone Medical, Inc.20089—
+6K263049SABER-C SystemElevation Spine20260—
+6K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+6K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+6K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+6K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+6K253195TAURUS Posterior Occipital-Cervico-Thoracic Spinal SystemsZheJiang Decans Medical Devices Co., Ltd.20260—
+6K261060Navigated LLIF Impactable TrackerTyber Medical, LLC20260—
+6K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+6K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—
+6K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+6K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+6K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+6K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+6K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+6K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+6K250773Luna® Ti Interbody Fusion SystemSpinal Elements, Inc.20260—
+6K254165Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20260—
+6K253158VyBrate™ VBR SystemVy Spine, LLC20260—
+6K252610ZSFab Lumbar Interbody SystemZsfab, Inc.20251—
+6K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+6K253129Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20250—
+6K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+6K253331PressON Spinal Fixation SystemNexus Spine20250—
+6K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+6K250076Endeavor™ Stand-Alone Cervical IBF SystemInnovasis20250—
+6K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+6K241525ExcelsiusXR™Globus Medical, Inc.20250—
+6K251725ANAX™ OCT Spinal SystemCg Medtech Co., Ltd.20250—
+6K243386Ventris Intervertebral Body Fusion DeviceAcuity Surgical Devices, LLC20252—
+6K243188Cylox® STSignus Medizintechnik GmbH20250—
+6K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+6K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+6K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+6K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+6K242734ZSFab Cervical Interbody System; ZSFab Lumbar Interbody SystemZsfab20243—
+6K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc.20241—
+6K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+6K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+6K241846E3D™-C Interbody SystemEvolution Spine20246—
+6K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+6K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody…Orthofix Medical, Inc.20242—
+6K241466Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System…SeaSpine Orthopedics Corporation20243—
+6K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+6K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+6K241396uCerv Flux™-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA, Inc.20240—
+6K240368E3D™-A Interbody SystemEvolution Spine20247—
+6K240625CORUS Navigation Access SystemProvidence Medical Technology, Inc.20244—
+6K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+6K240566Reef L Interbody System; WaveForm L Interbody SystemSeaSpine Orthopedics Corporation20245—