510(k) Report

Devices descending from K082235

693 later devices reach Blackstone Pillar XL Peek Spacers through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+6K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+6K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+6K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+6K232150ZSFab Cervical Interbody SystemZsfab, Inc.20234—
+6K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+6K230731Zavation ALIF SystemZavation Medical Products, LLC20232—
+6K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+6K220261NEST-C Interbody SystemPaonan Biotech Co., Ltd.20230—
+6K221324ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF)Camber Spine Technologies20230—
+6K223688CONDUIT™ Lateral Lumbar Intervertebral Fusion Cage, CONDUIT™ InstrumentsMedos International Sàrl20230—
+6K223731NuVasive Modulus-C Interbody SystemNuvasive, Inc.202311—
+6K2136534CIS Black Marlin Plif Cage System, 4CIS Dolphin Tlif Cage SystemSolco Biomedical Company India Private Limited20220—
+6K220696uCerv Flux-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA20221—
+6K220478NuVasive MOD-EX XLIF Interbody System, NuVasive MOD-EX XLIF Plated 2.0 Interbody SystemNu Vasive, Incorporated20222—
+6K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC20223—
+6K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20227—
+6K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+6K210214NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody SystemNu Vasive, Incorporated20213—
+6K210439NuVasive MOD-EX XLIF Interbody SystemNu Vasive, Incorporated20214—
+6K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc.202135—
+6K203201NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated202194—
+6K202488ZSFab Cervical Interbody SystemZsfab, Inc.20216—
+6K200549Lucero Medical Cervical Cage SystemLucero Medical, LLC20200—
+6K201755WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody SystemSeaSpine Orthopedics Corporation202017—
+6K201692NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated202067—
+6K201820NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated2020156—
+6K200991EVOL Spinal Interbody SystemCutting Edge Spine, LLC20200—
+6K200613Tritanium® X TL Expandable Curved Posterior Lumbar CageStryker Corporation20205—
+6K200312Tryptik TiSpineart20202—
+6K193593NuVasive 3DP Interfixated ALIF SystemNu Vasive, Incorporated2020157—
+6K192115SABLE Expandable SpacerGlobus Medical, Inc.202037—
+6K193359SureMAX Family of Cervical SpacersAdditive Implants, Inc.202014—
+6K192026Peridot Intervertebral body fusion SystemGbs Commonwealth Co., Ltd.20196—
+6K191477AEON-C Stand Alone SystemHuvexel Co., Ltd.201910—
+6K192760NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2019163—
+6K192214CarboClear VBR SystemCarboFix Orthopedics, Ltd.20191—
+6K192208CORNICE Cervical Spacer SystemLegend Spine Technologies20190—
+6K191391HEDRON Lumbar SpacersGlobus Medical, Inc.201984—
+6K190291Addivation Medical Cervical Interbody SystemAddivation Medical, LLC20190—
+6K183243Velofix TLIF CageU&I Corporation20190—
+6K183184FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.201912—
+6K182920MiRus™ Lumbar Interbody Fusion System consisting of CALLISTO™ PEEK Posterior Lumbar…MiRus, LLC20199—
+6K182477Cervical SpacerAdditive Implants, LLC201915—
+6K180822VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion SystemWenzel Spine, Inc.20195—
+6K182284Tyber Medical PT Interbody SpacerTyber Medical, LLC20195—
+6K182210TiWAVE-L Porous Titanium Lumbar CageKalitec Medical, LLC20193—
+6K181589Curiteva Lumbar Interbody Fusion SystemCuriteva, LLC20186—
+6K182470Plateau Spacer SystemLife Spine20180—
+6K181829Velofix TLIF CageU&I Corporation20181—
+6K181397DualXInnovasive, Inc.201815—
+6K180373CancelleX Porous Titanium Lumbar Interbody DeviceXenco Medical, LLC20180—
+6K181386NuVasive Brigade Lateral SystemNu Vasive, Incorporated2018158—
+6K180990TirboLOX-L Lumbar IBFDCaptiva Spine, Inc.20181—
+6K181014Tritanium PL CageStryker Spine2018137—
+6K180364HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC2018106—
+6K180401TiWAVE-C™ Porous Titanium Cervical CageKalitec Direct, LLC20185—
+6K173892NuVasive® XLX Interbody SystemNu Vasive, Incorporated2018115—
+6K180891EVOL Spinal Interbody System, EVOS Lumbar Interbody SystemCutting Edge Spine, LLC20181—
+6K173082Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20185—
+6K172941CASCADIA Interbody SystemK2m201852—
+6K171495Zyston Strut Open Titanium Spacer SystemZimmer Biomet Spine, Inc.20181—
+6K171312FortiCore®Nanovis, LLC20183—
+6K173159Cervical Spinal Truss System (CSTS) Interbody Fusion Device4Web, Inc.201812—
+6K172465Idys™ TLIF 3DTi CagesClariance, Sas20176—
+6K172676NuVasive® Modulus-C Interbody SystemNu Vasive, Incorporated2017125—
+6K170235Lucent®Spinal Elements, Inc.2017107—
+6K163595IMPIX 3D Print CagesMedicrea International SA2017282
+6K172392Lateral Spinal Truss System (LSTS) Interbody Fusion Device4Web, Inc.20171—
+6K172341NuVasive® Modulus TLIF Interbody SystemNu Vasive, Incorporated2017163—
+6K172123NuVasive® Modulus XLIF Interbody SystemNu Vasive, Incorporated2017227—
+6K171689ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2017109—
+6K170119Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc.201711
+6K171633NuVasive TLX Interbody SystemNu Vasive, Incorporated2017251—
+6K171351Posterior Spine Truss System (PSTS) Interbody Fusion Device4Web, Inc.20177—
+6K171140Matrixx SystemNexxt Spine, LLC2017145—
+6K170888Renovis S141 Lumbar Interbody Fusion SystemRenovis Surgical Technologies20175—
+6K170851Anterior Spine Truss System (STS) Interbody Fusion Device4Web, Inc.20175—
+6K170318NeoFuse Ti3D PLIF/TLIF/Cervical InterbodyHt Medical, LLC201749—
+6K170399Endoskeleton TO Interbody Fusion Device (IBD)Titan Spine, LLC2017105—
+6K170962NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated2017304—
+6K163670Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20173—
+6K163707NuVasive CoRoent Ti-C SystemNu Vasive, Incorporated201719—
+6K170592NuVasive BASE Interfixated Titanium SystemNu Vasive, Incorporated2017186—
+6K170643Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) SystemRti Surgical, Inc. Dba Rti Biologics201711—
+6K170055CAPRI Corpectomy Cage SystemK2m201711—
+6K163364MOJAVE Expandable Interbody SystemK2m201725—
+6K163409Rampart (TM) T Lumbar Interbody Fusion DeviceSpineology, Inc.20170—
+6K162879Elite Expandable Interbody Fusion DeviceSpineology, Inc.20179—
+6K160959Xsert Lumbar Expandable Interbody SystemX-Spine Systems, Inc.201612—
+6K162138NuVasive CoRoent Small Ti-C SystemNu Vasive, Incorporated2016135—
+6K162264Cascadia Interbody SystemK2m, Inc.2016169—
+6K153621Juliet® TiSpineart2016751
+6K160715AccuLIF TL and PL CageStryker Corporation20160—
+6K160547Cascadia Interbody SystemK2m2016157—
+6K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+7K261049Scala® TLSpineart SA20260—
+7K261408SABER-XA SystemElevation Spine20260—
+7K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+7K260837VersaLift Expandable SystemLife Spine, Inc.20260—