510(k) Report

Devices descending from K082262

722 later devices reach LDR Spine Roi Interbody Fusion System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K153495Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T…Ldr Spine USA20161891
+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—
+1K101310VU Apod Intervertebral Body Fusion DeviceTheken Spine, LLC2010480—
+1K100802Aesculap Implant Systems Sibd Spinal SystemAesculap Implant Systems, Inc.2010461—
+1K092901Epicage Interbody Fusion DeviceR Tree Innovations2010609—
+1K093808Incite Innovation Stand Alone Interbody Fusion DeviceIncite Innovation, LLC2010113—
+2K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+2K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20227—
+2K210583SeaSpine WaveForm™ A Interbody SystemSeaSpine Orthopedics Corporation202114—
+2K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc.202135—
+2K200879SeaSpine Meridian System, SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation202060—
+2K181818Scarlet AL-TSpineart201864—
+2K181591Fixated Asfora BULLET CAGE® (FABC)Medical Designs, LLC20180—
+2K173606SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu…SeaSpine Orthopedics Corporation201859—
+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—
+2K160605MectaLIF Anterior Stand-AloneMedacta International201610—
+2K153720ENZA Zero-Profile Anterior Interbody FusionCamber Spine Technologies20164—
+2K152620Spine Wave Gen II Expandable Interbody SystemSpine Wave, Inc.20162—
+2K151312VerteLP Interbody Fusion DeviceVgi, LLC201601
+2K142645Avenue T TLIF CageLdr Spine USA, Inc.2015191—
+2K142023Luna Interbody SystemBenvenue Medical, Inc.20145—
+2K133827A-Link ZOsteo Vasive, LLC2014262
+2K142066Aero-LL Lumbar Cage SystemStryker Corporation20142—
+2K141942Midline II TICentinel Spine, Inc.2014459—
+2K141129Exactech Cervical Spacer SystemExactech, Inc.20148—
+2K132907Plif Lite and Tlif LiteSintea Plustek20140—
+2K133286Midline (TM)Centinel Spine, Inc.2014460—
+2K124034Mectalif AnteriorMedacta International201311—
+2K130548Epicage Interbody Fusion DeviceAlphatec Spine, Inc.2013602—
+2K123134Easyspine SystemLdr Spine USA, Inc.20131—
+2K121211VU Apod Intervertebral Body Fusion DeviceTheken Spine, LLC2012129—
+2K111122Aesculap Sibd XP Spinal SystemAesculap Implant Systems, Inc.2011460—
+2K102402Solus Anterior Lumbar Interbody Fusion (Alif) Spinal Spacer SystemAlphatec Spine, Inc.20111121
+3K261408SABER-XA SystemElevation Spine20260—
+3K254202MectaLIF 3D Metal AnteriorMedacta International S.A.20260—
+3K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+3K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+3K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+3K250602X-PAC® N-GAGE™ Lumbar Plate SystemExpanding Innovations, Inc.20250—
+3K250603AxTiHA® Stand-Alone ALIF SystemInnovasis20250—
+3K2316554CIS® Chiron Spinal Fixation SystemSolco Biomedical Co., Ltd.20240—
+3K242589Scarlet® AL-TSpineart SA20240—
+3K233807LumiVy™ Lumbar IBF SystemVy Spine, LLC20241—
+3K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+3K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+3K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+3K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+3K233694Meridian Interbody System; WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20248—
+3K231486Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20231—
+3K232530Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemNexus Spine, LLC20235—
+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—
+3K223412LumiVy™ Lumbar IBF SystemVy Spine, LLC20235—
+3K222732WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20229—
+3K221719ABTross ALIF Expandable Cage SystemAegis Spine, Inc.20222—
+3K221545MectaLIF Anterior ExtensionMedacta International S.A.202226
+3K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+3K220523restor3d TiDAL Lumbar Interbody Fusion DeviceRestor3D20222—
+3K220711SeaSpine Meridian System, SeaSpine Meridian Anterior Plate SystemSeaSpine Orthopedics Corporation202210—
+3K212980Tesera-k ALIF SystemKyocera Medical Technologies, Inc.20222—
+3K210590Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20210—
+3K210497SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202139—
+3K201671A-Link ZAcuity Surgical Devices, LLC202125—
+3K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+3K201193SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202018—
+3K201769Cavetto [MAX] Cervical Cage SystemNeurostructures, Inc.20200—
+3K201087CORBEL SpacersGlobus Medical, Inc.202036—
+3K200048MectaLIF Anterior SimpleMedacta International S.A.20200—
+3K192906Mecta-C Stand AloneMedacta International S.A.20201—
+3K192993Scarlet AL-TSpineart20201—
+3K191391HEDRON Lumbar SpacersGlobus Medical, Inc.201984—
+3K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer…Choice Spine, LLC20194—
+3K190877Juliet® Ti LL Lumbar Interbody DeviceSpineart201911
+3K183426MectaLIF Anterior Stand Alone ExtensionMedacta International S.A.20191—
+3K181096Avenue P Cage SystemZimmer Biomet Spine, Inc.20190—
+3K182746ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc.2018110—
+3K181590Neurostructures Cavetto® [MAX] Cervical Cage SystemNeurostructures, Inc.20180—
+3K180963Roccia Alif, Roccia TlifSilony Medical GmbH20183—
+3K172816TiGer Shark™ SystemChoicespine, LP201859—
+3K171848FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO…Globus Medical, Inc.201755—
+3K172419Velofix™ TLIF CageU&I Corporation20172—
+3K172019Brisbane ALIF Device, Gladstone ALIF DeviceSignature Orthopaedics Pty, Ltd.20170—
+3K170157INDEPENDENCE® SpacersGlobus Medical, Inc.2017109—
+3K171686Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) SystemChoicespine2017116—
+3K162236Ax Stand-Alone ALIF SystemInnovasis, Inc.201774—
+3K170455MectaLIF Anterior Stand AloneMedacta International S.A.20174—
+3K162760Spine Wave Anterior Cervical Spine SystemSpine Wave, Inc.20171—
+3K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation201679—
+3K162431Luna 3D Interbody Fusion SystemBenvenue Medical, Inc.20163—
+3K153123Genesys Spine Apache Interbody Fusion SystemGenesys Spine201612—
+3K153356Spine Innovation Interbody SystemSpine Innovation, LLC20161—