510(k) Report

Devices descending from K110543

808 later devices reach Crescent (R) Spinal System Titanium through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K220953ChoiceSpine TigerShark™ M, Modular Interbody SystemChoice Spine, LLC20220—
+4K222082aprevo® anterior and lateral lumbar interbody fusion devices, aprevo® transforaminal…Carlsmed, Inc.202211—
+4K220523restor3d TiDAL Lumbar Interbody Fusion DeviceRestor3D20222—
+4K220581Zavation eZspand Interbody SystemZavation Medical Products, LLC20224—
+4K221180Anteralign (TM) Spinal System with Titan NanoLOCK Surface Technology Navigated InstrumentsMedtronic Sofamor Danek USA, Inc.20222—
+4K220115ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion SystemMiRus, LLC20220—
+4K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+4K220453FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20221—
+4K212520ProLift Micro Expandable Spacer SystemLife Spine, Inc.20216—
+4K211740DualXAmplify Surgical, Inc.20211—
+4K211689KEYSTONE PEEK Cage SystemShanghai Sanyou Medical Co, Ltd.20212—
+4K211769OneLIF Intervertebral Body Replacement SystemNovapproach Spine202112
+4K210800IO Expandable Lumbar Interbody Fusion SystemMiRus, LLC20212—
+4K210542aprevo Transforaminal IBFCarlsmed, Inc.202112—
+4K210595SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar SpacersCamber Spine Technologies, LLC20213—
+4K210214NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody SystemNu Vasive, Incorporated20213—
+4K201671A-Link ZAcuity Surgical Devices, LLC202125—
+4K201024Expandable Titanium PLIF/TLIF SystemSpectrum Spine, LLC20215—
+4K203038Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20215—
+4K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc.202135—
+4K203683CarboClear Lumbar Cage SystemCarbofix Orthpedics, Ltd.20211—
+4K202034aprevo Intervertebral Body Fusion DeviceCarlsmed, Inc.202017—
+4K201193SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202018—
+4K200316UNiD IB3D ALIFMedicrea International SA20200—
+4K201939GAIA Lumbar Interbody Fusion Device (LIFD) FamilyPrinterprezz20200—
+4K202190Oculus-SA Lumbar Cage SystemNeurostructures20200—
+4K201087CORBEL SpacersGlobus Medical, Inc.202036—
+4K200816SpineEX Sagittae Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20201—
+4K200541Hive™ Stand-alone Anterior Lumbar Interbody SystemHd Lifesciences, LLC20201—
+4K192492EL CAPITAN Anterior Lumber Interbody SystemAstura Medical, LLC202010—
+4K200312Tryptik TiSpineart20202—
+4K193378CarboClear Lumbar Cage SystemCarboFix Orthopedics, Ltd.20202—
+4K191796Neo Cage SystemNeo Medical SA20190—
+4K192248Cortina™ [MAX] Lumbar Cage SystemNeurostructures, Inc.20190—
+4K192434DualX Lumbar Intervertebral Body Fusion DeviceAmplify Surgical, Inc.20190—
+4K190488ProLift Expandable SystemLife Spine, Inc.201916—
+4K190959ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2019108—
+4K190193SpineEX Sagittae® Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20192—
+4K181048Neo Cage System TMNeo Medical SA20191—
+4K180230NEST Interbody SystemPaonan Biotech Co., Ltd.20191—
+4K181096Avenue P Cage SystemZimmer Biomet Spine, Inc.20190—
+4K182470Plateau Spacer SystemLife Spine20180—
+4K181818Scarlet AL-TSpineart201864—
+4K180990TirboLOX-L Lumbar IBFDCaptiva Spine, Inc.20181—
+4K180590Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20186—
+4K181203Juliet TiSpineart20181—
+4K173787X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage System…Medos International SARL20182—
+4K173189Lumfuse TPPrecifit Medical, Ltd.20180—
+4K180431Cortina [MAX] Lumbar Cage SystemNeurostructures, Inc.20181—
+4K172105The Plateau-LO Spacer SystemLife Spine, Inc.20181—
+4K172816TiGer Shark™ SystemChoicespine, LP201859—
+4K173702Juliet Ti LLSpineart20182—
+4K173182ProLift® Expandable SystemLife Spine, Inc.201737—
+4K172756Varian cageMedyssey USA, Inc.20171—
+4K170235Lucent®Spinal Elements, Inc.2017107—
+4K172083Idys™ ALIF SystemClariance, Sas20177—
+4K172328SOVEREIGN™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201730—
+4K171107CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal SystemMedtronic Sofamor Danek USA, Inc.20178—
+4K163422Shanghai Sanyou PEEK Cage SystemShanghai Sanyou Medical Co, Ltd.20173—
+4K171519FLXfit™Expanding Orthopedics, Inc.2017711
+4K170851Anterior Spine Truss System (STS) Interbody Fusion Device4Web, Inc.20175—
+4K171630LumFuse-TPPrecifit Medical, Ltd.20171—
+4K162212Divergence-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc.201757—
+4K163581Navigated ELEVATE Inserter, Navigated Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.2017103—
+4K162918Atlas Spine Expandable Interbody SystemAtlas Spine, Inc.201729—
+4K162680SOVEREIGN® Spinal SystemMedtronic Sofamor Danek USA, Inc.201631—
+4K162358T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution SystemSynthes USA Products, LLC2016127—
+4K161173Avenue® T TLIF CageLdr Spine USA, Inc.20163—
+4K161888JULIET® LL Lateral Lumbar CageSpineart2016145—
+4K161230NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated2016381—
+4K153495Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T…Ldr Spine USA20161891
+4K151726AVS AL and AVS ALign PEEK Spacers, AVS PL and AVS UniLIF PEEK Spacers, AVS TL PEEK…Stryker Corporation20161391
+4K152651AccuLIF TL and PL CageStryker Corporation201530—
+4K152304Tritanium PL CageStryker20154481
+4K152277PIVOX (tm) Oblique Lateral Spinal SystemMedtronic Sofamor Danek USA, Inc.2015190—
+4K151472NuVasive CoRoent Lumbar SystemNu Vasive, Incorporated2015479—
+4K142101Abacus (TM) Spacer SystemSpine Wave, Inc.20140—
+4K141217Acculif TL and PL CageStryker Corporation20146423
+5K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+5K253151Fule Interbody Fusion Cage SystemBeijing Fule Science & Technology Development Co., Ltd.20260—
+5K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+5K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+5K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+5K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+5K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+5K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine20260—
+5K254017SWINGO-3D Lumbar Cage SystemImplanet20260—
+5K253559Ventana™ A Anterior Lumbar Interbody SystemSpinal Elements, Inc.20260—
+5K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+5K250773Luna® Ti Interbody Fusion SystemSpinal Elements, Inc.20260—
+5K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+5K252610ZSFab Lumbar Interbody SystemZsfab, Inc.20251—
+5K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+5K252742Navigated InstrumentsTyber Medical, LLC20251—
+5K253377Expandable Titanium PLIF/TLIF SystemSpectrum Spine, Inc.20250—
+5K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+5K253331PressON Spinal Fixation SystemNexus Spine20250—
+5K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+5K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+5K251459OneLIF™ Interbody Fusion SystemNovapproach Spine, LLC20250—