510(k) Report

Devices descending from K072415

948 later devices reach Stalif (TM) C through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K223494CD Horizon Spinal SystemMedtronic202317—
+5K221542Galileo Vertebral Body Replacement DeviceBright Spine20230—
+5K223731NuVasive Modulus-C Interbody SystemNuvasive, Inc.202311—
+5K221266Cervical Spine Truss System (CSTS) Interbody Fusion Device4Web Medical, Inc.20233—
+5K2136534CIS Black Marlin Plif Cage System, 4CIS Dolphin Tlif Cage SystemSolco Biomedical Company India Private Limited20220—
+5K223251Hexanium PLIFSpinevision, S.A.S.20220—
+5K223153Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.20220—
+5K221182Southern Transforaminal Lumbar Interbody Fusion (TLIF)Southern Medical (Pty), Ltd.20220—
+5K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc.20221—
+5K222009aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.202212—
+5K222732WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20229—
+5K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+5K221936Standalone ALIF Interbody Fusion SystemEminent Spine20222—
+5K222276CONDUIT Cages; FIBERGRAFT BG PuttyDepuy Spine202229—
+5K221172FOCUS Interbody SystemOc Medical Devices20220—
+5K221646CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™…Medtronic Sofamor Danek USA, Inc.202220—
+5K213417Ghost Spacer SystemLife Spine, Inc.20220—
+5K221325CONDUIT Lateral Switch PlateMedos International SARL20221—
+5K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+5K222082aprevo® anterior and lateral lumbar interbody fusion devices, aprevo® transforaminal…Carlsmed, Inc.202211—
+5K220478NuVasive MOD-EX XLIF Interbody System, NuVasive MOD-EX XLIF Plated 2.0 Interbody SystemNu Vasive, Incorporated20222—
+5K220523restor3d TiDAL Lumbar Interbody Fusion DeviceRestor3D20222—
+5K212450Keos Anterior Cervical Interbody Fusion Device SystemKeos20220—
+5K220581Zavation eZspand Interbody SystemZavation Medical Products, LLC20224—
+5K221180Anteralign (TM) Spinal System with Titan NanoLOCK Surface Technology Navigated InstrumentsMedtronic Sofamor Danek USA, Inc.20222—
+5K220115ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion SystemMiRus, LLC20220—
+5K211837Altus Spine Interbody Standalone Fusion SystemAltus Partners, LLC20220—
+5K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC20223—
+5K220453FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20221—
+5K220096Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20220—
+5K211320CAPRI Corpectomy Cage SystemK2m, Inc.20222—
+5K214011Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™ TL Spinal…Medtronic Sofamor Danek USA, Inc.20221—
+5K213951FORZA XP Expandable Spacer SystemOrthofix US, LLC20224—
+5K212967AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.20211—
+5K212520ProLift Micro Expandable Spacer SystemLife Spine, Inc.20216—
+5K211740DualXAmplify Surgical, Inc.20211—
+5K211474Kleiner KG2 SystemBAAT Medical Products B.V.20210—
+5K212070KMTI S141 Lumbar Interbody Fusion SystemKyocera Medical Technologies, Inc.20210—
+5K211903Shoreline Threaded TruProfile® PlateSeaSpine Orthopedics Corporation20217—
+5K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+5K210800IO Expandable Lumbar Interbody Fusion SystemMiRus, LLC20212—
+5K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+5K210521DEXA-C Cervical Interbody SystemAurora Spine, Inc.20210—
+5K210044Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System…Spinal Elements, Inc.20211—
+5K210542aprevo Transforaminal IBFCarlsmed, Inc.202112—
+5K211306LabyrinthZavation Medical Products, LLC20213—
+5K200919Idys ALIF 3DTiClariance20210—
+5K202032Idys LLIF 3DTiClariance, Sas20210—
+5K203038Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20215—
+5K203361ProLift Wedge Expandable Spacer SystemLife Spine, Inc.20211—
+5K203207Omnia Medical TiBrid-SAOmnia Medical, LLC202012
+5K202637F3D Corpectomy SystemCorelink, LLC20201—
+5K201755WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody SystemSeaSpine Orthopedics Corporation202017—
+5K202034aprevo Intervertebral Body Fusion DeviceCarlsmed, Inc.202017—
+5K200316UNiD IB3D ALIFMedicrea International SA20200—
+5K201692NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated202067—
+5K201721TruLift Expandable Spacer SystemLife Spine, Inc.20205—
+5K192863MONDRIAN Lumbar Interbody Fusion Cage SystemCtl Medical Corporation20203—
+5K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+5K200920Idys ALIF ZP 3DTiClariance, Sas20203—
+5K200235KONG-TL VBR System, KONG-C VBR SystemIcotec AG20201—
+5K200991EVOL Spinal Interbody SystemCutting Edge Spine, LLC20200—
+5K200052CONSTRUX Mini PTC Spacer System, FORZA PTC Spacer System, PILLAR SA PTC Spacer SystemOrthofix, Inc.202013—
+5K193418SeaSpine Skipjack SystemSeaSpine Orthopedics Corporation20204—
+5K193506NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR SystemNu Vasive, Incorporated20201—
+5K193645nva, nvp, and nvtNvision Biomedical Technologies, Inc.20203—
+5K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine20207—
+5K191796Neo Cage SystemNeo Medical SA20190—
+5K192168Idys ALIF ZP 3DTiClariance, Sas20195—
+5K192434DualX Lumbar Intervertebral Body Fusion DeviceAmplify Surgical, Inc.20190—
+5K190708AccelFix Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20195—
+5K191354Ti3Z Cervical Interbody SystemZavation Medical Products, LLC201913—
+5K183249Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved…Stryker Spine20196—
+5K190488ProLift Expandable SystemLife Spine, Inc.201916—
+5K191005ProLift® Expandable SystemLife Spine, Inc.201918—
+5K191263Idys ALIF TiVacClariance, Sas20190—
+5K183560Luna 3D GEN2 Interbody Fusion SystemBenvenue Medical, Inc.20192—
+5K190165Capstone Control™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20196—
+5K182920MiRus™ Lumbar Interbody Fusion System consisting of CALLISTO™ PEEK Posterior Lumbar…MiRus, LLC20199—
+5K183705IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc.201999—
+5K181048Neo Cage System TMNeo Medical SA20191—
+5K180230NEST Interbody SystemPaonan Biotech Co., Ltd.20191—
+5K182470Plateau Spacer SystemLife Spine20180—
+5K180076Ti 3Z Interbody SystemZavation Medical Products, LLC20184—
+5K181079SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation201863—
+5K181261Curiteva Cervical Interbody Fusion SystemCuriteva, LLC20184—
+5K180590Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20186—
+5K180675Atlas Spine Expandable Cervical Interbody SystemAtlas Spine, Inc.20182—
+5K173787X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage System…Medos International SARL20182—
+5K180480ATEC Universal Spacer SystemAlphatec Spine, Inc.2018113—
+5K173722PATRIOT COLONIAL Spacer, SUSTAIN SpacerGlobus Medical, Inc.201894—
+5K173892NuVasive® XLX Interbody SystemNu Vasive, Incorporated2018115—
+5K180071STYLO Interbody Fusion DeviceLegend Spine Technologies20180—
+5K180002Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20182—
+5K180078Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF SystemInnovasis, Inc.2018551
+5K172816TiGer Shark™ SystemChoicespine, LP201859—
+5K172696FORZA® XP Expandable Spacer SystemOrthofix, Inc.201825—
+5K172676NuVasive® Modulus-C Interbody SystemNu Vasive, Incorporated2017125—
+5K172419Velofix™ TLIF CageU&I Corporation20172—
+5K173260SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica…SeaSpine Orthopedics Corporation201767—