510(k) Report

Devices descending from K100865

637 later devices reach Ava Navigator Peek Spacers, Model 48392XXX, 48393XXX through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K232432E3D™-A Interbody SystemEvolution Spine20248—
+4K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+4K233694Meridian Interbody System; WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20248—
+4K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+4K230478Acro Composites Interbody SystemAcro Composites, LLC20230—
+4K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+4K232150ZSFab Cervical Interbody SystemZsfab, Inc.20234—
+4K222874CarboClear Cervical Cage System, CarboClear Cervical VBR SystemCarbofix Orthpedics, Ltd.20230—
+4K231241NanoHive Medical Lumbar Interbody SystemNanoHive Medical, LLC20230—
+4K230731Zavation ALIF SystemZavation Medical Products, LLC20232—
+4K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+4K230851Kodiak Lumbar Spacer SystemMet One Technologies, LLC20230—
+4K231140aprevo® transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20236—
+4K220261NEST-C Interbody SystemPaonan Biotech Co., Ltd.20230—
+4K221324ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF)Camber Spine Technologies20230—
+4K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+4K223688CONDUIT™ Lateral Lumbar Intervertebral Fusion Cage, CONDUIT™ InstrumentsMedos International Sàrl20230—
+4K223174X-Pac Expandable LLIF Cage SystemExpanding Innovations, Inc.20233—
+4K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+4K223731NuVasive Modulus-C Interbody SystemNuvasive, Inc.202311—
+4K2136534CIS Black Marlin Plif Cage System, 4CIS Dolphin Tlif Cage SystemSolco Biomedical Company India Private Limited20220—
+4K222561AlignAcuity Surgical Devices, LLC202214—
+4K220696uCerv Flux-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA20221—
+4K221535Align Lumbar Interbody Fusion SystemAcuity Surgical Devices, LLC20223—
+4K220478NuVasive MOD-EX XLIF Interbody System, NuVasive MOD-EX XLIF Plated 2.0 Interbody SystemNu Vasive, Incorporated20222—
+4K220610SOLO-LAurora Spine, Inc.20220—
+4K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC20223—
+4K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20227—
+4K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+4K210542aprevo Transforaminal IBFCarlsmed, Inc.202112—
+4K210439NuVasive MOD-EX XLIF Interbody SystemNu Vasive, Incorporated20214—
+4K203201NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated202194—
+4K202488ZSFab Cervical Interbody SystemZsfab, Inc.20216—
+4K200549Lucero Medical Cervical Cage SystemLucero Medical, LLC20200—
+4K201755WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody SystemSeaSpine Orthopedics Corporation202017—
+4K201692NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated202067—
+4K201820NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated2020156—
+4K200991EVOL Spinal Interbody SystemCutting Edge Spine, LLC20200—
+4K200613Tritanium® X TL Expandable Curved Posterior Lumbar CageStryker Corporation20205—
+4K200312Tryptik TiSpineart20202—
+4K193593NuVasive 3DP Interfixated ALIF SystemNu Vasive, Incorporated2020157—
+4K193359SureMAX Family of Cervical SpacersAdditive Implants, Inc.202014—
+4K192026Peridot Intervertebral body fusion SystemGbs Commonwealth Co., Ltd.20196—
+4K191477AEON-C Stand Alone SystemHuvexel Co., Ltd.201910—
+4K192760NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2019163—
+4K192214CarboClear VBR SystemCarboFix Orthopedics, Ltd.20191—
+4K192208CORNICE Cervical Spacer SystemLegend Spine Technologies20190—
+4K191537eCarbon IBDsBack 2 Basics Direct, LLC20193—
+4K190291Addivation Medical Cervical Interbody SystemAddivation Medical, LLC20190—
+4K183243Velofix TLIF CageU&I Corporation20190—
+4K183184FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.201912—
+4K182920MiRus™ Lumbar Interbody Fusion System consisting of CALLISTO™ PEEK Posterior Lumbar…MiRus, LLC20199—
+4K182477Cervical SpacerAdditive Implants, LLC201915—
+4K180822VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion SystemWenzel Spine, Inc.20195—
+4K182284Tyber Medical PT Interbody SpacerTyber Medical, LLC20195—
+4K182210TiWAVE-L Porous Titanium Lumbar CageKalitec Medical, LLC20193—
+4K181589Curiteva Lumbar Interbody Fusion SystemCuriteva, LLC20186—
+4K182470Plateau Spacer SystemLife Spine20180—
+4K181829Velofix TLIF CageU&I Corporation20181—
+4K181397DualXInnovasive, Inc.201815—
+4K181386NuVasive Brigade Lateral SystemNu Vasive, Incorporated2018158—
+4K181014Tritanium PL CageStryker Spine2018137—
+4K180364HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC2018106—
+4K180401TiWAVE-C™ Porous Titanium Cervical CageKalitec Direct, LLC20185—
+4K173892NuVasive® XLX Interbody SystemNu Vasive, Incorporated2018115—
+4K180891EVOL Spinal Interbody System, EVOS Lumbar Interbody SystemCutting Edge Spine, LLC20181—
+4K173082Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20185—
+4K171495Zyston Strut Open Titanium Spacer SystemZimmer Biomet Spine, Inc.20181—
+4K171312FortiCore®Nanovis, LLC20183—
+4K173159Cervical Spinal Truss System (CSTS) Interbody Fusion Device4Web, Inc.201812—
+4K172676NuVasive® Modulus-C Interbody SystemNu Vasive, Incorporated2017125—
+4K170235Lucent®Spinal Elements, Inc.2017107—
+4K172392Lateral Spinal Truss System (LSTS) Interbody Fusion Device4Web, Inc.20171—
+4K172341NuVasive® Modulus TLIF Interbody SystemNu Vasive, Incorporated2017163—
+4K172123NuVasive® Modulus XLIF Interbody SystemNu Vasive, Incorporated2017227—
+4K171689ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2017109—
+4K170119Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc.201711
+4K171633NuVasive TLX Interbody SystemNu Vasive, Incorporated2017251—
+4K171351Posterior Spine Truss System (PSTS) Interbody Fusion Device4Web, Inc.20177—
+4K171140Matrixx SystemNexxt Spine, LLC2017145—
+4K170851Anterior Spine Truss System (STS) Interbody Fusion Device4Web, Inc.20175—
+4K170318NeoFuse Ti3D PLIF/TLIF/Cervical InterbodyHt Medical, LLC201749—
+4K170399Endoskeleton TO Interbody Fusion Device (IBD)Titan Spine, LLC2017105—
+4K170962NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated2017304—
+4K163670Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20173—
+4K163707NuVasive CoRoent Ti-C SystemNu Vasive, Incorporated201719—
+4K170592NuVasive BASE Interfixated Titanium SystemNu Vasive, Incorporated2017186—
+4K170643Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) SystemRti Surgical, Inc. Dba Rti Biologics201711—
+4K170055CAPRI Corpectomy Cage SystemK2m201711—
+4K163364MOJAVE Expandable Interbody SystemK2m201725—
+4K163409Rampart (TM) T Lumbar Interbody Fusion DeviceSpineology, Inc.20170—
+4K162879Elite Expandable Interbody Fusion DeviceSpineology, Inc.20179—
+4K160959Xsert Lumbar Expandable Interbody SystemX-Spine Systems, Inc.201612—
+4K162138NuVasive CoRoent Small Ti-C SystemNu Vasive, Incorporated2016135—
+4K162264Cascadia Interbody SystemK2m, Inc.2016169—
+4K160715AccuLIF TL and PL CageStryker Corporation20160—
+5K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+5K262094E3D™-C Interbody SystemEvolution Spine20260—
+5K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+5K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—