510(k) Report

Devices descending from K090507

281 later devices reach Modification to LDR Spine Roi Interbody Fusion System; Roi-a Implant System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K173518Spectrum Spine Expandable Cages (SSEC)Spectrum Spine, LLC20196—
+1K153495Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T…Ldr Spine USA20161891
+1K122639Synthes Syncage Evolution SpacerSynthes (USA) Products, LLC2013143—
+1K121103LDR Spine Usa Spine Tune, TL Spinal System, LDR Spine Usa Easyspine, Posterior Spinal…Ldr Spine USA, Inc.201216—
+1K113285LDR Spine Usa Avenue L Interbody FusionLdr Spine USA, Inc.2012199—
+1K110327LDR Spine Roi-a Interbody Fusion SystemLdr Spine USA2011241—
+2K243074Spectrum Spine Lumbar Cage SystemSpectrum Spine, Inc.20252—
+2K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+2K201024Expandable Titanium PLIF/TLIF SystemSpectrum Spine, LLC20215—
+2K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc.202135—
+2K202820Australis Anterior Lumbar Cage SystemPrism Surgical Designs Pty, Ltd.20200—
+2K181899Roccia® PlifSilony Medical GmbH20180—
+2K181591Fixated Asfora BULLET CAGE® (FABC)Medical Designs, LLC20180—
+2K181702Tranquil-L Interbody SystemNexus Spine, LLC20188—
+2K172320Neurostructures Cavetto® Cervical Cage SystemNeurostructures, Inc.20183—
+2K163474CAVUX CervicalCage-L SA SystemProvidence Medical Technology, Inc.20170—
+2K162103Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine…Choicespine, LP2016161—
+2K161173Avenue® T TLIF CageLdr Spine USA, Inc.20163—
+2K160597INDEPENDENCE MIS SpacersGlobus Medical, Inc.2016111—
+2K153720ENZA Zero-Profile Anterior Interbody FusionCamber Spine Technologies20164—
+2K152620Spine Wave Gen II Expandable Interbody SystemSpine Wave, Inc.20162—
+2K151312VerteLP Interbody Fusion DeviceVgi, LLC201601
+2K151408LOSPA IS Spinal SystemCorentec Co., Ltd.20151—
+2K150673SYNFIX Evolution Secured Spacer SystemSynthes (USA) Products, LLC2015137—
+2K142645Avenue T TLIF CageLdr Spine USA, Inc.2015191—
+2K133827A-Link ZOsteo Vasive, LLC2014262
+2K142066Aero-LL Lumbar Cage SystemStryker Corporation20142—
+2K141129Exactech Cervical Spacer SystemExactech, Inc.20148—
+2K123134Easyspine SystemLdr Spine USA, Inc.20131—
+3K261408SABER-XA SystemElevation Spine20260—
+3K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine20260—
+3K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+3K253377Expandable Titanium PLIF/TLIF SystemSpectrum Spine, Inc.20250—
+3K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+3K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc.20251—
+3K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+3K2316554CIS® Chiron Spinal Fixation SystemSolco Biomedical Co., Ltd.20240—
+3K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+3K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+3K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+3K233375Tranquil-L Interbody SystemNexus Spine, LLC20240—
+3K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+3K230607SPICCA Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+3K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+3K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+3K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+3K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+3K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+3K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20227—
+3K212075ShurFit Lumbar Interbody SystemPrecision Spine, Inc.20211—
+3K210590Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20210—
+3K201671A-Link ZAcuity Surgical Devices, LLC202125—
+3K201769Cavetto [MAX] Cervical Cage SystemNeurostructures, Inc.20200—
+3K201585Monterey AL Interbody SystemStryker Corporation202044
+3K201087CORBEL SpacersGlobus Medical, Inc.202036—
+3K191391HEDRON Lumbar SpacersGlobus Medical, Inc.201984—
+3K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer…Choice Spine, LLC20194—
+3K181096Avenue P Cage SystemZimmer Biomet Spine, Inc.20190—
+3K181590Neurostructures Cavetto® [MAX] Cervical Cage SystemNeurostructures, Inc.20180—
+3K180695FBC 921 (Alif)Fbc Device Aps20180—
+3K180963Roccia Alif, Roccia TlifSilony Medical GmbH20183—
+3K180002Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20182—
+3K172816TiGer Shark™ SystemChoicespine, LP201859—
+3K171848FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO…Globus Medical, Inc.201755—
+3K172419Velofix™ TLIF CageU&I Corporation20172—
+3K170157INDEPENDENCE® SpacersGlobus Medical, Inc.2017109—
+3K171686Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) SystemChoicespine2017116—
+3K170243LOSPA IS TLIF & DLIF CagesCorentec Co., Ltd.20170—
+3K162760Spine Wave Anterior Cervical Spine SystemSpine Wave, Inc.20171—
+3K162358T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution SystemSynthes USA Products, LLC2016127—
+3K150130Ascendant TM Cervical Spacer SystemExactech, Inc.20157—
+4K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+4K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+4K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+4K253260ORIO-3D Cage SystemSpineCraft20260—
+4K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+4K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+4K252610ZSFab Lumbar Interbody SystemZsfab, Inc.20251—
+4K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+4K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting20250—
+4K243386Ventris Intervertebral Body Fusion DeviceAcuity Surgical Devices, LLC20252—
+4K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—
+4K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+4K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+4K241846E3D™-C Interbody SystemEvolution Spine20246—
+4K240368E3D™-A Interbody SystemEvolution Spine20247—
+4K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+4K233694Meridian Interbody System; WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20248—
+4K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+4K231486Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20231—
+4K232530Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemNexus Spine, LLC20235—
+4K230894NuVasive Modulus ALIF SystemNu Vasive, Incorporated20234—
+4K230731Zavation ALIF SystemZavation Medical Products, LLC20232—
+4K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+4K223688CONDUIT™ Lateral Lumbar Intervertebral Fusion Cage, CONDUIT™ InstrumentsMedos International Sàrl20230—
+4K223146EVOLUTION SPINE Interbody SystemEvolution Spine20239—
+4K2136534CIS Black Marlin Plif Cage System, 4CIS Dolphin Tlif Cage SystemSolco Biomedical Company India Private Limited20220—
+4K222009aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.202212—
+4K221936Standalone ALIF Interbody Fusion SystemEminent Spine20222—
+4K221172FOCUS Interbody SystemOc Medical Devices20220—