510(k) Report

Devices descending from K042201

796 later devices reach Novel VBR Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K223043The Integrity Spine Core SystemIntegrity Spine20230—
+5K213030Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc.20233—
+5K221844TDM Lumbar Interbody Fusion Cage SystemTdm Co., Ltd.20221—
+5K213791Unispace SA Cervical CageEdisoninno Co., Ltd.20222—
+5K221535Align Lumbar Interbody Fusion SystemAcuity Surgical Devices, LLC20223—
+5K212126MediExpand Cervical Expandable VBR SystemCmf Medicon Surgical, Inc.20220—
+5K213118Dakota ALIF SystemPrecision Spine, Inc.20220—
+5K212075ShurFit Lumbar Interbody SystemPrecision Spine, Inc.20211—
+5K210573Velofix SA Cervical CageU&I Corporation20211—
+5K211413BEE PLIF CageNGMedical GmbH20211—
+5K202032Idys LLIF 3DTiClariance, Sas20210—
+5K200429BEE CagesNGMedical GmbH202111—
+5K203683CarboClear Lumbar Cage SystemCarbofix Orthpedics, Ltd.20211—
+5K203076Mecta-C Stand Alone ExtensionMedacta International S.A.20200—
+5K202065DOLOMITE Anterior Cervical Stabilization SystemAstura Medical, LLC20203—
+5K202190Oculus-SA Lumbar Cage SystemNeurostructures20200—
+5K200685RIGEL 3DR Anterior Cervical Interbody Fusion SystemMiRus, LLC20200—
+5K200312Tryptik TiSpineart20202—
+5K192897icotec Cervical CageIcotec AG20201—
+5K193378CarboClear Lumbar Cage SystemCarboFix Orthopedics, Ltd.20202—
+5K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine20207—
+5K190284Bengal Stackable Cage SystemMedos International SARL20190—
+5K1920444CIS Marlin PEEK ACIF CageSolco Biomedical Co., Ltd.20190—
+5K182987Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20199—
+5K192248Cortina™ [MAX] Lumbar Cage SystemNeurostructures, Inc.20190—
+5K190426ALTA Anterior Cervical Corpectomy SystemAstura Medical, LLC20193—
+5K183407Triton CageMedyssey USA, Inc.20190—
+5K192054Endoskeleton TAS PlateTitan Spine, Inc.20190—
+5K192018Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic…Titan Spine, Inc.20191024
+5K191565Endoskeleton TCS Interbody Fusion DeviceTitan Spine, Inc.201901
+5K183426MectaLIF Anterior Stand Alone ExtensionMedacta International S.A.20191—
+5K183259Idys™ TLIF TiVacClariance, Sas20191—
+5K183557Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device…Titan Spine, Inc.20191043
+5K183447EIT Cellular Titanium Lumbar Cage - T/PLIFEit Emerging Implant Technologies GmbH2019131—
+5K183071VLIFT-s Vertebral Body Replacement SystemStryker Spine20194—
+5K183239CoreLink F3D™ Lateral SystemCorelink, LLC20188—
+5K180665SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage SystemK2m, LLC20189—
+5K182195Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20183—
+5K181860NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2018159—
+5K181328T2 STRATOSPHERE™ Expandable Corpectomy SystemMedtronic Sofamor Danek USA, Inc.201828—
+5K181347Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC201824—
+5K180814CoreLink® M3™ Stand-Alone Anterior Lumbar SystemCorelink, LLC201818—
+5K180556Corelink Foundation 3D Anterior Lumbar SystemCorelink, LLC20185—
+5K181115CxHA PEEK Cervical IBF SystemInnovasis, Inc.20188—
+5K180673Normandy VBR SystemZavation Medical Products, LLC20187—
+5K180675Atlas Spine Expandable Cervical Interbody SystemAtlas Spine, Inc.20182—
+5K180642Pro-Link® Ti Stand-Alone Cervical Spacer SystemLife Spine, Inc.20182—
+5K173347STALIF C FLX, STALIF M FLX, STALIF L FLX and STALIF Lateral-Oblique FLX, ACTILIF C FLX…Centinel Spine, Inc.201812—
+5K173128Alamo® CAlliance Partners, LLC20182—
+5K180431Cortina [MAX] Lumbar Cage SystemNeurostructures, Inc.20181—
+5K173324ALTA Anterior Cervical Interbody SpacerAstura Medical201827—
+5K173535Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TAS Hyperlordotic Interbody…Titan Spine, LLC20181052
+5K173159Cervical Spinal Truss System (CSTS) Interbody Fusion Device4Web, Inc.201812—
+5K172465Idys™ TLIF 3DTi CagesClariance, Sas20176—
+5K172888EIT Cellular Titanium® Cervical Cages, EIT Cellular Titanium® PLIF Cages, EIT Cellular…Eit Emerging Implant Technologies GmbH2017159—
+5K172419Velofix™ TLIF CageU&I Corporation20172—
+5K172424Velofix™ SA Cervical CageU&I Corporation201751
+5K172083Idys™ ALIF SystemClariance, Sas20177—
+5K172446SPIRA-C Open Matrix Cervical InterbodyCamber Spine Technologies20176—
+5K172064Ti-Diagon Oblique TLIFCamber Spine Technologies201727—
+5K171657ShurFit 2C Lumbar Interbody Fusion SystemPrecision Spine, Inc.20174—
+5K170399Endoskeleton TO Interbody Fusion Device (IBD)Titan Spine, LLC2017105—
+5K163506Coalesce™ (-Straight, -Convex, -Crescent, -Lateral, -Anterior, or -Oblique) Lumbar…Vertera, Inc.2017224—
+5K163481HALF DOME Posterior Lumbar Interbody SystemAstura Medical201731—
+5K163269Endoskeleton (R) TAS Interbody Fusion Device / Endoskeleton (R) TAS Hyperlordotic…Titan Spine, LLC2017143—
+5K170455MectaLIF Anterior Stand AloneMedacta International S.A.20174—
+5K143578SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers…Globus Medical, Inc.2016210—
+5K151406Cogent Lateral Interbody SystemCogent Spine, LLC201611—
+5K152475FORZA PTC Spacer SystemOrthofix, Inc.2016236—
+5K153122Endoskeleton (r) TCS SystemTitan Spine, LLC20151061
+5K151596Endoskeleton TCS Interbody Fusion DeviceTitan Spine, LLC20151101
+5K142152Construx Mini Peek; Spacer System, TI Spacer System, Cervical Stand Alone SystemOrthofix, Inc.2015280—
+5K141942Midline II TICentinel Spine, Inc.2014459—
+5K142193Cogent Med-Lif XLCogent Spine, LLC201412—
+5K1421124WEB Spinal Implant Products4Web, Inc.201433—
+5K141129Exactech Cervical Spacer SystemExactech, Inc.20148—
+5K140864Veloxtm Interbody Fusion SystemU&I Corp.20149—
+5K132926Velofixtm Interbody Fusion SystemU&I Corp.201410—
+6K262726NeckTune™ SA Cervical CageMedyssey Co., Ltd.20260—
+6K260840BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20261—
+6K242303MOD-COrthomod, LLC20260—
+6K253559Ventana™ A Anterior Lumbar Interbody SystemSpinal Elements, Inc.20260—
+6K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+6K254061Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc.20260—
+6K250769Dakota LP SystemPrecision Spine, Inc.20250—
+6K252351UniSpace® TPLIF CageCg Medtech Co., Ltd.20250—
+6K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+6K250076Endeavor™ Stand-Alone Cervical IBF SystemInnovasis20250—
+6K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting20250—
+6K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+6K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+6K251335Tera Lumbar Interbody Fusion System (Various PNs)Acuity Surgical Devices, LLC20251—
+6K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+6K241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc.20241—
+6K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc.20241—
+6K2402503D Printed PEEK Interbody SystemNvision Biomedical Technologies, Inc.20240—
+6K241738PYXIS 3D Titanium Cervical Cage systemGS Medical Co., Ltd.20241—
+6K241413sagAlign Lumbar Cage System (Various PNs)Acuity Surgical Devices, LLC20240—
+6K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+6K240699SCARLET® AC-TiSpineart SA20240—