510(k) Report

Devices descending from K083626

660 later devices reach Distractable Wave Cage through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+3K153695Biomet Spine Fusion SystemBiomet Spine, LLC201632
+3K152259InFill Interbody Fusion DevicePinnacle Spine Group, LLC20152—
+3K142996StaXx (R) XD SystemSpine Wave, Inc.20150—
+3K140007Abacus TM Spacer SystemSpine Wave, Inc.20144—
+3K132719Staxx Ibl SystemSpine Wave, Inc.20137—
+4K261049Scala® TLSpineart SA20260—
+4K2530413d Cage CervicalFims Co., Ltd.20260—
+4K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+4K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+4K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+4K261067BEE PLIF CageNGMedical GmbH20260—
+4K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+4K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+4K250773Luna® Ti Interbody Fusion SystemSpinal Elements, Inc.20260—
+4K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+4K253577IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)Medicrea International S.A.S. (Medtronic)20250—
+4K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+4K251479Mobarn 80:20 Lumbar Interbody Fusion System (Posterior Lumbar Interbody Fusion Cage…Mobarn Medical Devices, LLC20250—
+4K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting20250—
+4K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+4K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc.20251—
+4K241525ExcelsiusXR™Globus Medical, Inc.20250—
+4K250987aprevo® posterior/transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20251—
+4K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+4K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+4K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+4K241396uCerv Flux™-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA, Inc.20240—
+4K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+4K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+4K234087restor3d TIDAL Lumbar Interbody Fusion SystemRestor3D20240—
+4K233414Shoreline ACS Interbody System; Shoreline RT Interbody SystemSeaSpine Orthopedics Corporation20238—
+4K230478Acro Composites Interbody SystemAcro Composites, LLC20230—
+4K232154MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate FixationMiRus, LLC20230—
+4K232150ZSFab Cervical Interbody SystemZsfab, Inc.20234—
+4K222874CarboClear Cervical Cage System, CarboClear Cervical VBR SystemCarbofix Orthpedics, Ltd.20230—
+4K231275Exceed™ Biplanar Expandable Interbody SystemSpine Wave, Inc.20232—
+4K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+4K220261NEST-C Interbody SystemPaonan Biotech Co., Ltd.20230—
+4K223326Axiom PSR SystemRestor3D202301
+4K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+4K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+4K223362Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device4Web Medical, Inc.20233—
+4K223731NuVasive Modulus-C Interbody SystemNuvasive, Inc.202311—
+4K221266Cervical Spine Truss System (CSTS) Interbody Fusion Device4Web Medical, Inc.20233—
+4K222806Kodiak C Spinal Implant SystemMet One Technologies, LLC20221—
+4K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+4K221172FOCUS Interbody SystemOc Medical Devices20220—
+4K222383Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX Stealth (TM)…Medtronic Sofamor Danek USA, Inc.20220—
+4K220696uCerv Flux-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA20221—
+4K220478NuVasive MOD-EX XLIF Interbody System, NuVasive MOD-EX XLIF Plated 2.0 Interbody SystemNu Vasive, Incorporated20222—
+4K221180Anteralign (TM) Spinal System with Titan NanoLOCK Surface Technology Navigated InstrumentsMedtronic Sofamor Danek USA, Inc.20222—
+4K212527Cervical Spine Truss System Plating Solution (CSTS-PS)4Web Medical, Inc.20220—
+4K220711SeaSpine Meridian System, SeaSpine Meridian Anterior Plate SystemSeaSpine Orthopedics Corporation202210—
+4K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+4K214010Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA202249—
+4K213355Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20224—
+4K220453FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20221—
+4K212980Tesera-k ALIF SystemKyocera Medical Technologies, Inc.20222—
+4K211845Deploy Expandable Interbody SystemSouthern Spine, LLC20210—
+4K211704CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini PTC Spacer…Orthofix, Inc.20215—
+4K212070KMTI S141 Lumbar Interbody Fusion SystemKyocera Medical Technologies, Inc.20210—
+4K211413BEE PLIF CageNGMedical GmbH20211—
+4K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+4K211388Lateral Spine Truss System (LSTS) Interbody Fusion Device4Web Medical, Inc.20210—
+4K210595SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar SpacersCamber Spine Technologies, LLC20213—
+4K210583SeaSpine WaveForm™ A Interbody SystemSeaSpine Orthopedics Corporation202114—
+4K210214NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody SystemNu Vasive, Incorporated20213—
+4K210439NuVasive MOD-EX XLIF Interbody SystemNu Vasive, Incorporated20214—
+4K203038Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20215—
+4K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc.202135—
+4K200429BEE CagesNGMedical GmbH202111—
+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—
+4K202198FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20202—
+4K200316UNiD IB3D ALIFMedicrea International SA20200—
+4K201692NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated202067—
+4K202190Oculus-SA Lumbar Cage SystemNeurostructures20200—
+4K201367FlareHawk TiHawk9 Interbody Fusion SystemIntegrity Implants, Inc.20202—
+4K200958MODULIF-A Anterior Lumbar Interbody Fusion SystemSpinal Stability, LLC20200—
+4K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+4K200685RIGEL 3DR Anterior Cervical Interbody Fusion SystemMiRus, LLC20200—
+4K193153SPIRA-C Integrated Fixation SystemCamber Spine Technologies20202—
+4K200052CONSTRUX Mini PTC Spacer System, FORZA PTC Spacer System, PILLAR SA PTC Spacer SystemOrthofix, Inc.202013—
+4K200312Tryptik TiSpineart20202—
+4K193593NuVasive 3DP Interfixated ALIF SystemNu Vasive, Incorporated2020157—
+4K193203MOJAVE Expandable Interbody SystemK2m, Inc.202015—
+4K191581Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion…Titan Spine, Inc.202081—
+4K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine20207—
+4K193359SureMAX Family of Cervical SpacersAdditive Implants, Inc.202014—
+4K191796Neo Cage SystemNeo Medical SA20190—
+4K182987Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20199—
+4K192336Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.201917—
+4K191477AEON-C Stand Alone SystemHuvexel Co., Ltd.201910—
+4K192168Idys ALIF ZP 3DTiClariance, Sas20195—
+4K1803473d CageFims Co., Ltd.20190—
+4K192760NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2019163—
+4K192208CORNICE Cervical Spacer SystemLegend Spine Technologies20190—
+4K191537eCarbon IBDsBack 2 Basics Direct, LLC20193—