510(k) Report

Devices descending from K082235

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K202034aprevo Intervertebral Body Fusion DeviceCarlsmed, Inc.202017—
+7K202198FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20202—
+7K202949CONSTRUX Mini PEEK Spacer SystemOrthofix, Inc.20206—
+7K202666CONSTRUX Mini PTC Spacer SystemOrthofix, Inc.202010—
+7K200953NuVasive® Cohere® Thoracolumbar Interbody SystemNu Vasive, Incorporated2020141—
+7K202190Oculus-SA Lumbar Cage SystemNeurostructures20200—
+7K201367FlareHawk TiHawk9 Interbody Fusion SystemIntegrity Implants, Inc.20202—
+7K200958MODULIF-A Anterior Lumbar Interbody Fusion SystemSpinal Stability, LLC20200—
+7K192863MONDRIAN Lumbar Interbody Fusion Cage SystemCtl Medical Corporation20203—
+7K201267Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek202079—
+7K201087CORBEL SpacersGlobus Medical, Inc.202036—
+7K200969NEXXT MATRIXX SystemNexxt Spine, LLC20200—
+7K200352Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20202—
+7K191906MiRus 3D Printed Lumbar Interbody Fusion Systems consisting of the Callisto 3D Printed…MiRus, LLC20206—
+7K192145Galileo Vertebral Body Replacement DeviceBright Spine20201—
+7K193541NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2020157—
+7K193506NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR SystemNu Vasive, Incorporated20201—
+7K193412NEXXT MATRIXX SystemNexxt Spine, LLC20201—
+7K193203MOJAVE Expandable Interbody SystemK2m, Inc.202015—
+7K192993Scarlet AL-TSpineart20201—
+7K193370Nexxt Matrixx SystemNexxt Spine, LLC20202—
+7K192687TrellOss™-L MPFNexxt Spine, LLC20201—
+7K191581Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion…Titan Spine, Inc.202081—
+7K191834Stand-Alone ALIF Titanium SystemLife Spine, Inc.20190—
+7K192168Idys ALIF ZP 3DTiClariance, Sas20195—
+7K191134IB3D AlifMedicrea International SA20191—
+7K1803473d CageFims Co., Ltd.20190—
+7K192434DualX Lumbar Intervertebral Body Fusion DeviceAmplify Surgical, Inc.20190—
+7K191822Nano FortiCore, FortiCoreNanovis, LLC20192—
+7K191354Ti3Z Cervical Interbody SystemZavation Medical Products, LLC201913—
+7K192018Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic…Titan Spine, Inc.20191024
+7K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer…Choice Spine, LLC20194—
+7K190870Cervical Spinal Truss System-Stand Alone (CSTS-SA)4Web, Inc.201910—
+7K191311ATEC Lateral Interbody SystemAlphatec Spine, Inc.201978—
+7K182158UNiD Patient-matched PLIF cageMedicrea International SA201921—
+7K191408Nexxt Matrixx SystemNexxt Spine, LLC20190—
+7K190959ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2019108—
+7K190618RIGEL PEEK Anterior Cervical Interbody Fusion SystemMiRus, LLC20191—
+7K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC201993—
+7K190092UNiD Patient specific 3D printed TLIF cageMedicrea International SA201913—
+7K183397ChoiceSpine Stealth Cervical Spacer SystemChoicespine, LP201916—
+7K183557Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device…Titan Spine, Inc.20191043
+7K183447EIT Cellular Titanium Lumbar Cage - T/PLIFEit Emerging Implant Technologies GmbH2019131—
+7K182584Lucent® XPSpinal Elements, Inc.20183—
+7K180665SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage SystemK2m, LLC20189—
+7K182746ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc.2018110—
+7K182195Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20183—
+7K181837Spinal Elements Ti-Bond coated devicesSpinal Elements, Inc.201898—
+7K181818Scarlet AL-TSpineart201864—
+7K181860NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2018159—
+7K181229TirboLOX-C Cervical IBFDCaptiva Spine, Inc.20180—
+7K181655Renovis S180 Lateral Lumbar Interbody Fusion SystemRenovis Surgical Technologies20184—
+7K181435ATEC Cervical Spacer SystemAlphatec Spine, Inc.2018100—
+7K181347Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC201824—
+7K180777K2M Expandable Interbody SystemK2m, Inc.20180—
+7K181453ATEC ALIF Spacer SystemAlphatec Spine, Inc.2018111—
+7K181203Juliet TiSpineart20181—
+7K180480ATEC Universal Spacer SystemAlphatec Spine, Inc.2018113—
+7K173782UNiD Patient Specific 3D printed cageMedicrea International SA201823—
+7K180002Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20182—
+7K180078Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF SystemInnovasis, Inc.2018551
+7K173025NuVasive® MLX® – Medial Lateral Expandable Lumbar Interbody System; NuVasive® AP…Nu Vasive, Incorporated20188—
+7K173702Juliet Ti LLSpineart20182—
+7K172009Cascadia Interbody SystemK2m, Inc.2017433
+7K173153Vertera Spine™ Coalesce™ Thoracolumbar Interbody Fusion SystemNu Vasive, Incorporated2017160—
+7K172328SOVEREIGN™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201730—
+7K172343Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D TechnologyRti Surgical, Inc.201710—
+7K171893Blustone Synergy Lumbar Interbody Fusion System (Basalt, Magma, Obsidian), Blustone…Bluestone Synergy20172—
+7K171704CAPRI Corpectomy Cage SystemK2m201710—
+7K171425Concorde LiftMedos International SARL201782
+7K170676HD Lumbar Interbody SystemHd Lifesciences, LLC2017122—
+7K170297Tranquil Interbody SystemNexus Spine, LLC201715—
+7K170961NuVasive CoRoent Small Interlock II SystemNu Vasive, Incorporated201718—
+7K171097MOJAVE Expandable Interbody SystemK2m, Inc.201717—
+8K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc.20260—
+8K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—
+8K261810Vertiwedge® Intraosseous SystemFoundation Surgical Group20260—
+8K262094E3D™-C Interbody SystemEvolution Spine20260—
+8K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+8K260810Anteralign LS coverplateTyber Medical, LLC20260—
+8K260549ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemZsfab, Inc.20260—
+8K260340HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC…HC Biologics, LLC20260—
+8K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine20260—
+8K253583LUX Expandable Lumbar Interbody SystemXenix Medical20260—
+8K253545Vulcan Spinal SystemK2m, Inc.20260—
+8K260038E3D™-C Interbody SystemEvolution Spine20261—
+8K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+8K252711Advantage-C™ Ti3D Cervical Interbody Fusion DeviceIntelivation Technologies20260—
+8K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+8K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+8K253577IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)Medicrea International S.A.S. (Medtronic)20250—
+8K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc.20250—
+8K252610ZSFab Lumbar Interbody SystemZsfab, Inc.20251—
+8K250769Dakota LP SystemPrecision Spine, Inc.20250—
+8K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+8K251444Endoskeleton™ Interbody SystemsMedtronic Sofamor Danek USA, Inc.20250—
+8K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+8K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+8K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+8K251459OneLIF™ Interbody Fusion SystemNovapproach Spine, LLC20250—