510(k) Report

Devices descending from K100043

744 later devices reach Coroent XLR Standalone System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K230329F3D Interbody SystemCorelink, LLC20230—
+3K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+3K223688CONDUIT™ Lateral Lumbar Intervertebral Fusion Cage, CONDUIT™ InstrumentsMedos International Sàrl20230—
+3K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+3K223731NuVasive Modulus-C Interbody SystemNuvasive, Inc.202311—
+3K223105Tesera-K SC SystemKyocera Medical Technologies, Inc.20225—
+3K2136534CIS Black Marlin Plif Cage System, 4CIS Dolphin Tlif Cage SystemSolco Biomedical Company India Private Limited20220—
+3K223065Adcura® Sagittae® Lateral Lumbar Interbody Fusion DevicesAdcura, Inc.20220—
+3K221751NuVasive Cohere ALIF System Intervertebral Body Fusion DeviceNu Vasive, Incorporated20223—
+3K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+3K222276CONDUIT Cages; FIBERGRAFT BG PuttyDepuy Spine202229—
+3K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+3K220478NuVasive MOD-EX XLIF Interbody System, NuVasive MOD-EX XLIF Plated 2.0 Interbody SystemNu Vasive, Incorporated20222—
+3K220523restor3d TiDAL Lumbar Interbody Fusion DeviceRestor3D20222—
+3K214010Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA202249—
+3K202266Reliance Cervical IBF SystemReliance Medical Systems, LLC20223—
+3K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20227—
+3K213980Peridot Spinal Interbody SystemGbs Commonwealth Co., Ltd.20224—
+3K212524Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.202155—
+3K212075ShurFit Lumbar Interbody SystemPrecision Spine, Inc.20211—
+3K212653Catalyft LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.202127
+3K210590Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20210—
+3K211805IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec…Alphatec Spine, Inc.202138—
+3K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+3K211258Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA…Medtronic Sofamor Danek USA, Inc.202175—
+3K210214NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody SystemNu Vasive, Incorporated20213—
+3K210425Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.2021561
+3K210439NuVasive MOD-EX XLIF Interbody SystemNu Vasive, Incorporated20214—
+3K201671A-Link ZAcuity Surgical Devices, LLC202125—
+3K200919Idys ALIF 3DTiClariance20210—
+3K202032Idys LLIF 3DTiClariance, Sas20210—
+3K210271NuVasive Modulus ALIF SystemNu Vasive, Incorporated20215—
+3K202872Prase PEEK Anterior Cervical Interbody SpacerGbs Commonwealth Co., Ltd.20215—
+3K202190Oculus-SA Lumbar Cage SystemNeurostructures20200—
+3K201267Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek202079—
+3K200920Idys ALIF ZP 3DTiClariance, Sas20203—
+3K200352Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20202—
+3K200991EVOL Spinal Interbody SystemCutting Edge Spine, LLC20200—
+3K200816SpineEX Sagittae Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20201—
+3K200541Hive™ Stand-alone Anterior Lumbar Interbody SystemHd Lifesciences, LLC20201—
+3K192492EL CAPITAN Anterior Lumber Interbody SystemAstura Medical, LLC202010—
+3K193541NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2020157—
+3K193593NuVasive 3DP Interfixated ALIF SystemNu Vasive, Incorporated2020157—
+3K192993Scarlet AL-TSpineart20201—
+3K192115SABLE Expandable SpacerGlobus Medical, Inc.202037—
+3K191581Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion…Titan Spine, Inc.202081—
+3K191834Stand-Alone ALIF Titanium SystemLife Spine, Inc.20190—
+3K182987Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20199—
+3K192582NuVasive CoRoent Small Interlock SystemNu Vasive, Incorporated201930—
+3K192168Idys ALIF ZP 3DTiClariance, Sas20195—
+3K191134IB3D AlifMedicrea International SA20191—
+3K192760NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2019163—
+3K191066CD Horizon™ Astute™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201921—
+3K191391HEDRON Lumbar SpacersGlobus Medical, Inc.201984—
+3K192054Endoskeleton TAS PlateTitan Spine, Inc.20190—
+3K183249Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved…Stryker Spine20196—
+3K190680Favo S-TlifSilony Medical GmbH20190—
+3K182158UNiD Patient-matched PLIF cageMedicrea International SA201921—
+3K190959ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2019108—
+3K182139AXTi Titanium Stand-Alone ALIF SystemInnovasis, Inc.201972—
+3K191263Idys ALIF TiVacClariance, Sas20190—
+3K190092UNiD Patient specific 3D printed TLIF cageMedicrea International SA201913—
+3K190165Capstone Control™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20196—
+3K190193SpineEX Sagittae® Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20192—
+3K182007Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies20180—
+3K182470Plateau Spacer SystemLife Spine20180—
+3K181621Stable-C Interbody SystemNexus Spine, LLC20187—
+3K181860NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2018159—
+3K181229TirboLOX-C Cervical IBFDCaptiva Spine, Inc.20180—
+3K180590Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20186—
+3K173892NuVasive® XLX Interbody SystemNu Vasive, Incorporated2018115—
+3K180071STYLO Interbody Fusion DeviceLegend Spine Technologies20180—
+3K173782UNiD Patient Specific 3D printed cageMedicrea International SA201823—
+3K173082Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20185—
+3K173077Cavetto-SA Cervical Cage SystemNeurostructures, Inc.201821—
+3K173535Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TAS Hyperlordotic Interbody…Titan Spine, LLC20181052
+3K173102Reliance Cervical IBF SystemReliance Medical Systems, LLC201715—
+3K173182ProLift® Expandable SystemLife Spine, Inc.201737—
+3K173115COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and…Globus Medical, Inc.201783—
+3K172009Cascadia Interbody SystemK2m, Inc.2017433
+3K172019Brisbane ALIF Device, Gladstone ALIF DeviceSignature Orthopaedics Pty, Ltd.20170—
+3K172341NuVasive® Modulus TLIF Interbody SystemNu Vasive, Incorporated2017163—
+3K172123NuVasive® Modulus XLIF Interbody SystemNu Vasive, Incorporated2017227—
+3K170119Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc.201711
+3K171633NuVasive TLX Interbody SystemNu Vasive, Incorporated2017251—
+3K170157INDEPENDENCE® SpacersGlobus Medical, Inc.2017109—
+3K171656Genesys Spine Apache Interbody Fusion SystemGenesys Spine20170—
+3K170962NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated2017304—
+3K163707NuVasive CoRoent Ti-C SystemNu Vasive, Incorporated201719—
+3K163230NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2017276—
+3K161993Leva® Anterior Interbody SystemSpine Wave, Inc.20160—
+3K162138NuVasive CoRoent Small Ti-C SystemNu Vasive, Incorporated2016135—
+3K161379ELSA SpacersGlobus Medical, Inc.2016155—
+3K161223TransContinental® M Spacers and InterContinental® Plate-SpacersGlobus Medical, Inc.2016117—
+3K153786Prow Fusion-VNlt Spine, Ltd.20166—
+3K153123Genesys Spine Apache Interbody Fusion SystemGenesys Spine201612—
+3K153627NuVasive® TLX Interbody SystemNu Vasive, Incorporated2016252—
+3K151312VerteLP Interbody Fusion DeviceVgi, LLC201601
+3K151310Amendia Interbody Fusion DevicesAmendia, Inc.2016169—
+3K151481Sahara Stabilization SystemK2m, Inc.20155—