510(k) Report

Devices descending from K141665

588 later devices reach NuVasive CoRoent System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+3K241525ExcelsiusXR™Globus Medical, Inc.20250—
+3K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc.20250—
+3K250373ProLift Expandable Spacer SystemLife Spine, Inc.20251—
+3K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+3K243668ProLift Pivot Expandable Spacer SystemLife Spine, Inc.20250—
+3K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+3K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+3K242734ZSFab Cervical Interbody System; ZSFab Lumbar Interbody SystemZsfab20243—
+3K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+3K240889ARTFX Lumbar PEEK CagesArtfx Medical20244—
+3K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+3K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+3K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+3K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+3K232611TruLift Micro Expandable Spacer System & TruLift Expandable Spacer SystemLife Spine, Inc.20232—
+3K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+3K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+3K222988neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D CervicalHt Medical D.B.A. Xenix Medical20232—
+3K231680AccelFix Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20231—
+3K230607SPICCA Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+3K231275Exceed™ Biplanar Expandable Interbody SystemSpine Wave, Inc.20232—
+3K231735NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody…Nu Vasive, Incorporated20239—
+3K230894NuVasive Modulus ALIF SystemNu Vasive, Incorporated20234—
+3K230329F3D Interbody SystemCorelink, LLC20230—
+3K230851Kodiak Lumbar Spacer SystemMet One Technologies, LLC20230—
+3K223335SIRION Lateral Lumbar Interbody SystemAstura Medical20230—
+3K220513NITRO Interbody Fusion Cage System FamilyCtl Medical Corporation20230—
+3K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+3K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc.20221—
+3K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+3K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+3K221751NuVasive Cohere ALIF System Intervertebral Body Fusion DeviceNu Vasive, Incorporated20223—
+3K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+3K213641MONDRIAN ALIF Cage with Supplementary Fixation PlateCtl Medical Corporation20221—
+3K221325CONDUIT Lateral Switch PlateMedos International SARL20221—
+3K220523restor3d TiDAL Lumbar Interbody Fusion DeviceRestor3D20222—
+3K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+3K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+3K213420WaveForm L System, WaveForm TO System, WaveForm TA SystemSeaSpine Orthopedics Corporation202211—
+3K211837Altus Spine Interbody Standalone Fusion SystemAltus Partners, LLC20220—
+3K220453FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20221—
+3K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20227—
+3K213980Peridot Spinal Interbody SystemGbs Commonwealth Co., Ltd.20224—
+3K203714NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System…Nu Vasive, Incorporated202166—
+3K212904SeaSpine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202115—
+3K213359SeaSpine WaveForm, C Interbody SystemSeaSpine Orthopedics Corporation20217—
+3K211740DualXAmplify Surgical, Inc.20211—
+3K211805IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec…Alphatec Spine, Inc.202138—
+3K211474Kleiner KG2 SystemBAAT Medical Products B.V.20210—
+3K212540Explorer TO SystemSeaSpine Orthopedics Corporation20213—
+3K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+3K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+3K210497SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202139—
+3K210583SeaSpine WaveForm™ A Interbody SystemSeaSpine Orthopedics Corporation202114—
+3K211258Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA…Medtronic Sofamor Danek USA, Inc.202175—
+3K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+3K203038Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20215—
+3K210271NuVasive Modulus ALIF SystemNu Vasive, Incorporated20215—
+3K202872Prase PEEK Anterior Cervical Interbody SpacerGbs Commonwealth Co., Ltd.20215—
+3K203531XYPAN Expandable Lumbar Cage SystemAegis Spine, Inc.20213—
+3K200458Tailored-C Cervical Interbody Fusion SystemBespoke Technologies20203—
+3K201193SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202018—
+3K201939GAIA Lumbar Interbody Fusion Device (LIFD) FamilyPrinterprezz20200—
+3K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+3K200879SeaSpine Meridian System, SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation202060—
+3K200969NEXXT MATRIXX SystemNexxt Spine, LLC20200—
+3K191906MiRus 3D Printed Lumbar Interbody Fusion Systems consisting of the Callisto 3D Printed…MiRus, LLC20206—
+3K200991EVOL Spinal Interbody SystemCutting Edge Spine, LLC20200—
+3K193506NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR SystemNu Vasive, Incorporated20201—
+3K193255Largo PEEK Interbody SystemFlospine, LLC20201—
+3K193521Steerable Plateau TiLife Spine, Inc.20201—
+3K193258ProLift Expandable SystemLife Spine, Inc.20203—
+3K192115SABLE Expandable SpacerGlobus Medical, Inc.202037—
+3K182987Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20199—
+3K192434DualX Lumbar Intervertebral Body Fusion DeviceAmplify Surgical, Inc.20190—
+3K191391HEDRON Lumbar SpacersGlobus Medical, Inc.201984—
+3K191311ATEC Lateral Interbody SystemAlphatec Spine, Inc.201978—
+3K183249Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved…Stryker Spine20196—
+3K183064TxTi IBF SystemInnovasis, Inc.2019481
+3K190684LxHA PEEK Lateral IBF SystemInnovasis, Inc.20190—
+3K190618RIGEL PEEK Anterior Cervical Interbody Fusion SystemMiRus, LLC20191—
+3K183184FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.201912—
+3K183397ChoiceSpine Stealth Cervical Spacer SystemChoicespine, LP201916—
+3K183705IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc.201999—
+3K183083Shoreline Cervical Interbody RT SystemSeaSpine Orthopedics Corporation201960—
+3K183557Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device…Titan Spine, Inc.20191043
+3K180822VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion SystemWenzel Spine, Inc.20195—
+3K183239CoreLink F3D™ Lateral SystemCorelink, LLC20188—
+3K182746ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc.2018110—
+3K181386NuVasive Brigade Lateral SystemNu Vasive, Incorporated2018158—
+3K181435ATEC Cervical Spacer SystemAlphatec Spine, Inc.2018100—
+3K180814CoreLink® M3™ Stand-Alone Anterior Lumbar SystemCorelink, LLC201818—
+3K180556Corelink Foundation 3D Anterior Lumbar SystemCorelink, LLC20185—
+3K181453ATEC ALIF Spacer SystemAlphatec Spine, Inc.2018111—
+3K181079SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation201863—
+3K173787X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage System…Medos International SARL20182—
+3K173606SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu…SeaSpine Orthopedics Corporation201859—
+3K173082Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20185—
+3K171434ROCCIA® MultiLIFSilony Medical GmbH20174—