510(k) Report

Devices descending from K073470

1,102 later devices reach Avs PL Peek Spacers, Models 48351XXX and 48353XXX through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K231763Stable-C Interbody SystemNexus Spine, LLC20236—
+5K232150ZSFab Cervical Interbody SystemZsfab, Inc.20234—
+5K230607SPICCA Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+5K230608SPICCA Stand-Alone Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+5K231275Exceed™ Biplanar Expandable Interbody SystemSpine Wave, Inc.20232—
+5K231808QUASAR Standalone ACIF SystemGS Medical Co., Ltd.20230—
+5K231241NanoHive Medical Lumbar Interbody SystemNanoHive Medical, LLC20230—
+5K231735NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody…Nu Vasive, Incorporated20239—
+5K230851Kodiak Lumbar Spacer SystemMet One Technologies, LLC20230—
+5K231140aprevo® transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20236—
+5K223335SIRION Lateral Lumbar Interbody SystemAstura Medical20230—
+5K220261NEST-C Interbody SystemPaonan Biotech Co., Ltd.20230—
+5K230808PEEK SA Anterior Lumbar Interbody Fusion (ALIF) SystemKyocera Medical Technologies, Inc.20230—
+5K221324ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF)Camber Spine Technologies20230—
+5K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+5K223688CONDUIT™ Lateral Lumbar Intervertebral Fusion Cage, CONDUIT™ InstrumentsMedos International Sàrl20230—
+5K223174X-Pac Expandable LLIF Cage SystemExpanding Innovations, Inc.20233—
+5K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+5K223362Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device4Web Medical, Inc.20233—
+5K223412LumiVy™ Lumbar IBF SystemVy Spine, LLC20235—
+5K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+5K2136534CIS Black Marlin Plif Cage System, 4CIS Dolphin Tlif Cage SystemSolco Biomedical Company India Private Limited20220—
+5K223190Hive™ Standalone Cervical SystemNanoHive Medical, LLC20225—
+5K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc.20221—
+5K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+5K222732WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20229—
+5K221719ABTross ALIF Expandable Cage SystemAegis Spine, Inc.20222—
+5K221545MectaLIF Anterior ExtensionMedacta International S.A.202226
+5K221751NuVasive Cohere ALIF System Intervertebral Body Fusion DeviceNu Vasive, Incorporated20223—
+5K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+5K220953ChoiceSpine TigerShark™ M, Modular Interbody SystemChoice Spine, LLC20220—
+5K221325CONDUIT Lateral Switch PlateMedos International SARL20221—
+5K220696uCerv Flux-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA20221—
+5K220523restor3d TiDAL Lumbar Interbody Fusion DeviceRestor3D20222—
+5K212450Keos Anterior Cervical Interbody Fusion Device SystemKeos20220—
+5K212527Cervical Spine Truss System Plating Solution (CSTS-PS)4Web Medical, Inc.20220—
+5K220711SeaSpine Meridian System, SeaSpine Meridian Anterior Plate SystemSeaSpine Orthopedics Corporation202210—
+5K213420WaveForm L System, WaveForm TO System, WaveForm TA SystemSeaSpine Orthopedics Corporation202211—
+5K211837Altus Spine Interbody Standalone Fusion SystemAltus Partners, LLC20220—
+5K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC20223—
+5K220453FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20221—
+5K213980Peridot Spinal Interbody SystemGbs Commonwealth Co., Ltd.20224—
+5K220096Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20220—
+5K212358Romero Cervical CageSpineup, Inc.20226—
+5K212980Tesera-k ALIF SystemKyocera Medical Technologies, Inc.20222—
+5K203714NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System…Nu Vasive, Incorporated202166—
+5K212715Vy Spine ClariVy Cervical IBF SystemVy Spine, LLC20216—
+5K212904SeaSpine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202115—
+5K213359SeaSpine WaveForm, C Interbody SystemSeaSpine Orthopedics Corporation20217—
+5K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210—
+5K211740DualXAmplify Surgical, Inc.20211—
+5K211474Kleiner KG2 SystemBAAT Medical Products B.V.20210—
+5K201793EDEN Peek CageJmt Co., Ltd.20210—
+5K212540Explorer TO SystemSeaSpine Orthopedics Corporation20213—
+5K211769OneLIF Intervertebral Body Replacement SystemNovapproach Spine202112
+5K210090Impulse AM Interbody Fusion SystemDegen Medical20217—
+5K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+5K211501Advantage-C PEEK Cervical lnterbody Fusion DeviceLntelivation, LLC20211—
+5K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+5K210497SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202139—
+5K210542aprevo Transforaminal IBFCarlsmed, Inc.202112—
+5K211258Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA…Medtronic Sofamor Danek USA, Inc.202175—
+5K203038Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20215—
+5K210271NuVasive Modulus ALIF SystemNu Vasive, Incorporated20215—
+5K210155Duo Expandable Interbody Fusion SystemSpineology, Inc.20210—
+5K202872Prase PEEK Anterior Cervical Interbody SpacerGbs Commonwealth Co., Ltd.20215—
+5K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+5K202488ZSFab Cervical Interbody SystemZsfab, Inc.20216—
+5K202495SIRION Lateral Lumbar Interbody FusionAstura Medical, LLC20216—
+5K201287Impulse Interbody Fusion SystemDegen Medical20208—
+5K200549Lucero Medical Cervical Cage SystemLucero Medical, LLC20200—
+5K201193SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202018—
+5K202305Zavation IBF SystemZavation Medical Products, LLC20209—
+5K201939GAIA Lumbar Interbody Fusion Device (LIFD) FamilyPrinterprezz20200—
+5K200958MODULIF-A Anterior Lumbar Interbody Fusion SystemSpinal Stability, LLC20200—
+5K201500Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar SpacerLife Spine, Inc.20203—
+5K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+5K191906MiRus 3D Printed Lumbar Interbody Fusion Systems consisting of the Callisto 3D Printed…MiRus, LLC20206—
+5K200991EVOL Spinal Interbody SystemCutting Edge Spine, LLC20200—
+5K200613Tritanium® X TL Expandable Curved Posterior Lumbar CageStryker Corporation20205—
+5K200312Tryptik TiSpineart20202—
+5K192006SIRION Lateral Lumbar Interbody SystemAstura Medical, LLC202014—
+5K191788CAPSTONE Spinal System, CLYDESDALE PTC Spinal System, CRESCENT Spinal System, CRESCENT…Medtronic Sofamor Danek USA, Inc.20200—
+5K200048MectaLIF Anterior SimpleMedacta International S.A.20200—
+5K192906Mecta-C Stand AloneMedacta International S.A.20201—
+5K193506NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR SystemNu Vasive, Incorporated20201—
+5K193255Largo PEEK Interbody SystemFlospine, LLC20201—
+5K193521Steerable Plateau TiLife Spine, Inc.20201—
+5K193320KMTI Tesera SA Anterior Lumbar Interbody Fusion (ALIF) SystemKyocera Medical Technologies, Inc.20203—
+5K193258ProLift Expandable SystemLife Spine, Inc.20203—
+5K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+5K192993Scarlet AL-TSpineart20201—
+5K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine20207—
+5K193359SureMAX Family of Cervical SpacersAdditive Implants, Inc.202014—
+5K191477AEON-C Stand Alone SystemHuvexel Co., Ltd.201910—
+5K192434DualX Lumbar Intervertebral Body Fusion DeviceAmplify Surgical, Inc.20190—
+5K192214CarboClear VBR SystemCarboFix Orthopedics, Ltd.20191—
+5K192208CORNICE Cervical Spacer SystemLegend Spine Technologies20190—
+5K190483SPIRA Open Matrix ALIF and LLIFCamber Spine Technologies20199—
+5K192047Rampart™ One Lumbar Interbody Fusion SystemSpineology, Inc.20190—