510(k) Report

Devices descending from K080699

798 later devices reach Novel Spinal Spacer System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K213359SeaSpine WaveForm, C Interbody SystemSeaSpine Orthopedics Corporation20217—
+4K211740DualXAmplify Surgical, Inc.20211—
+4K211474Kleiner KG2 SystemBAAT Medical Products B.V.20210—
+4K212540Explorer TO SystemSeaSpine Orthopedics Corporation20213—
+4K211449Triton™ Sacroiliac Joint Fixation SystemChoice Spine, LLC20211—
+4K212070KMTI S141 Lumbar Interbody Fusion SystemKyocera Medical Technologies, Inc.20210—
+4K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+4K210382Blustone Synergy Diamond SA Cervical SystemBlustone Synergy, LLC20210—
+4K210497SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202139—
+4K210583SeaSpine WaveForm™ A Interbody SystemSeaSpine Orthopedics Corporation202114—
+4K211258Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA…Medtronic Sofamor Danek USA, Inc.202175—
+4K210425Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.2021561
+4K203038Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20215—
+4K210271NuVasive Modulus ALIF SystemNu Vasive, Incorporated20215—
+4K202872Prase PEEK Anterior Cervical Interbody SpacerGbs Commonwealth Co., Ltd.20215—
+4K203531XYPAN Expandable Lumbar Cage SystemAegis Spine, Inc.20213—
+4K202488ZSFab Cervical Interbody SystemZsfab, Inc.20216—
+4K200458Tailored-C Cervical Interbody Fusion SystemBespoke Technologies20203—
+4K200549Lucero Medical Cervical Cage SystemLucero Medical, LLC20200—
+4K201193SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202018—
+4K201453Fortilink Cages with TiPlus TechnologyParadigm Spine GmbH20204—
+4K201506Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical…Meditech Spine, LLC20200—
+4K200958MODULIF-A Anterior Lumbar Interbody Fusion SystemSpinal Stability, LLC20200—
+4K201267Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek202079—
+4K201614TxTiHA IBF System, AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.2020471
+4K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+4K200879SeaSpine Meridian System, SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation202060—
+4K200969NEXXT MATRIXX SystemNexxt Spine, LLC20200—
+4K191906MiRus 3D Printed Lumbar Interbody Fusion Systems consisting of the Callisto 3D Printed…MiRus, LLC20206—
+4K200991EVOL Spinal Interbody SystemCutting Edge Spine, LLC20200—
+4K200541Hive™ Stand-alone Anterior Lumbar Interbody SystemHd Lifesciences, LLC20201—
+4K200312Tryptik TiSpineart20202—
+4K193506NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR SystemNu Vasive, Incorporated20201—
+4K193255Largo PEEK Interbody SystemFlospine, LLC20201—
+4K193203MOJAVE Expandable Interbody SystemK2m, Inc.202015—
+4K193521Steerable Plateau TiLife Spine, Inc.20201—
+4K193258ProLift Expandable SystemLife Spine, Inc.20203—
+4K192115SABLE Expandable SpacerGlobus Medical, Inc.202037—
+4K191581Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion…Titan Spine, Inc.202081—
+4K193359SureMAX Family of Cervical SpacersAdditive Implants, Inc.202014—
+4K191796Neo Cage SystemNeo Medical SA20190—
+4K182987Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20199—
+4K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+4K191477AEON-C Stand Alone SystemHuvexel Co., Ltd.201910—
+4K192168Idys ALIF ZP 3DTiClariance, Sas20195—
+4K191134IB3D AlifMedicrea International SA20191—
+4K192434DualX Lumbar Intervertebral Body Fusion DeviceAmplify Surgical, Inc.20190—
+4K191822Nano FortiCore, FortiCoreNanovis, LLC20192—
+4K192208CORNICE Cervical Spacer SystemLegend Spine Technologies20190—
+4K191537eCarbon IBDsBack 2 Basics Direct, LLC20193—
+4K191391HEDRON Lumbar SpacersGlobus Medical, Inc.201984—
+4K191354Ti3Z Cervical Interbody SystemZavation Medical Products, LLC201913—
+4K192018Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic…Titan Spine, Inc.20191024
+4K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer…Choice Spine, LLC20194—
+4K183249Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved…Stryker Spine20196—
+4K182158UNiD Patient-matched PLIF cageMedicrea International SA201921—
+4K190959ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2019108—
+4K190618RIGEL PEEK Anterior Cervical Interbody Fusion SystemMiRus, LLC20191—
+4K190092UNiD Patient specific 3D printed TLIF cageMedicrea International SA201913—
+4K183184FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.201912—
+4K190055Duo Lumbar Interbody Fusion DeviceSpineology, Inc.20191—
+4K183397ChoiceSpine Stealth Cervical Spacer SystemChoicespine, LP201916—
+4K182406Altus Spine Interbody Fusion SystemAltus Partners, LLC20191—
+4K183588Choice Spine Hawkeye Vertebral Body Replacement (VBR) SystemChoicespine20195—
+4K183083Shoreline Cervical Interbody RT SystemSeaSpine Orthopedics Corporation201960—
+4K183557Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device…Titan Spine, Inc.20191043
+4K181048Neo Cage System TMNeo Medical SA20191—
+4K182477Cervical SpacerAdditive Implants, LLC201915—
+4K180822VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion SystemWenzel Spine, Inc.20195—
+4K183239CoreLink F3D™ Lateral SystemCorelink, LLC20188—
+4K180665SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage SystemK2m, LLC20189—
+4K181921Solidity Vertebral Body ReplacementUlrich Medical USA20182—
+4K181621Stable-C Interbody SystemNexus Spine, LLC20187—
+4K181818Scarlet AL-TSpineart201864—
+4K181702Tranquil-L Interbody SystemNexus Spine, LLC20188—
+4K181229TirboLOX-C Cervical IBFDCaptiva Spine, Inc.20180—
+4K181655Renovis S180 Lateral Lumbar Interbody Fusion SystemRenovis Surgical Technologies20184—
+4K181483Tranquil Interbody SystemNexus Spine, LLC20186—
+4K181386NuVasive Brigade Lateral SystemNu Vasive, Incorporated2018158—
+4K180814CoreLink® M3™ Stand-Alone Anterior Lumbar SystemCorelink, LLC201818—
+4K180777K2M Expandable Interbody SystemK2m, Inc.20180—
+4K180556Corelink Foundation 3D Anterior Lumbar SystemCorelink, LLC20185—
+4K181079SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation201863—
+4K181115CxHA PEEK Cervical IBF SystemInnovasis, Inc.20188—
+4K181203Juliet TiSpineart20181—
+4K180364HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC2018106—
+4K180401TiWAVE-C™ Porous Titanium Cervical CageKalitec Direct, LLC20185—
+4K173787X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage System…Medos International SARL20182—
+4K173832InTice™-C Porous Ti Cervical Interbody SystemX-Spine Systems, Inc.201801
+4K173782UNiD Patient Specific 3D printed cageMedicrea International SA201823—
+4K173606SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu…SeaSpine Orthopedics Corporation201859—
+4K173082Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20185—
+4K171495Zyston Strut Open Titanium Spacer SystemZimmer Biomet Spine, Inc.20181—
+4K172816TiGer Shark™ SystemChoicespine, LP201859—
+4K171312FortiCore®Nanovis, LLC20183—
+4K173702Juliet Ti LLSpineart20182—
+4K171434ROCCIA® MultiLIFSilony Medical GmbH20174—
+4K172926SeaSpine Vu cPOD, Zuma-C, Complete CervicalSeaSpine Orthopedics Corporation201761—
+4K173153Vertera Spine™ Coalesce™ Thoracolumbar Interbody Fusion SystemNu Vasive, Incorporated2017160—
+4K173260SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica…SeaSpine Orthopedics Corporation201767—