510(k) Report

Devices descending from K110327

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K160597INDEPENDENCE MIS SpacersGlobus Medical, Inc.2016111—
+1K153720ENZA Zero-Profile Anterior Interbody FusionCamber Spine Technologies20164—
+1K153495Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T…Ldr Spine USA20161891
+1K133827A-Link ZOsteo Vasive, LLC2014262
+1K113285LDR Spine Usa Avenue L Interbody FusionLdr Spine USA, Inc.2012199—
+2K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+2K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+2K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+2K210590Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20210—
+2K201671A-Link ZAcuity Surgical Devices, LLC202125—
+2K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc.202135—
+2K201087CORBEL SpacersGlobus Medical, Inc.202036—
+2K191391HEDRON Lumbar SpacersGlobus Medical, Inc.201984—
+2K181591Fixated Asfora BULLET CAGE® (FABC)Medical Designs, LLC20180—
+2K180963Roccia Alif, Roccia TlifSilony Medical GmbH20183—
+2K171848FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO…Globus Medical, Inc.201755—
+2K170157INDEPENDENCE® SpacersGlobus Medical, Inc.2017109—
+2K162103Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine…Choicespine, LP2016161—
+2K161173Avenue® T TLIF CageLdr Spine USA, Inc.20163—
+2K152620Spine Wave Gen II Expandable Interbody SystemSpine Wave, Inc.20162—
+2K151312VerteLP Interbody Fusion DeviceVgi, LLC201601
+2K142645Avenue T TLIF CageLdr Spine USA, Inc.2015191—
+2K142066Aero-LL Lumbar Cage SystemStryker Corporation20142—
+3K261408SABER-XA SystemElevation Spine20260—
+3K253260ORIO-3D Cage SystemSpineCraft20260—
+3K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+3K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+3K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting20250—
+3K243386Ventris Intervertebral Body Fusion DeviceAcuity Surgical Devices, LLC20252—
+3K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+3K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+3K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+3K240368E3D™-A Interbody SystemEvolution Spine20247—
+3K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+3K233694Meridian Interbody System; WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20248—
+3K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+3K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+3K230894NuVasive Modulus ALIF SystemNu Vasive, Incorporated20234—
+3K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+3K230731Zavation ALIF SystemZavation Medical Products, LLC20232—
+3K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+3K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+3K223146EVOLUTION SPINE Interbody SystemEvolution Spine20239—
+3K222009aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.202212—
+3K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+3K221936Standalone ALIF Interbody Fusion SystemEminent Spine20222—
+3K222561AlignAcuity Surgical Devices, LLC202214—
+3K222082aprevo® anterior and lateral lumbar interbody fusion devices, aprevo® transforaminal…Carlsmed, Inc.202211—
+3K221535Align Lumbar Interbody Fusion SystemAcuity Surgical Devices, LLC20223—
+3K220610SOLO-LAurora Spine, Inc.20220—
+3K220115ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion SystemMiRus, LLC20220—
+3K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20227—
+3K212075ShurFit Lumbar Interbody SystemPrecision Spine, Inc.20211—
+3K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+3K210595SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar SpacersCamber Spine Technologies, LLC20213—
+3K203207Omnia Medical TiBrid-SAOmnia Medical, LLC202012
+3K202034aprevo Intervertebral Body Fusion DeviceCarlsmed, Inc.202017—
+3K201585Monterey AL Interbody SystemStryker Corporation202044
+3K183249Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved…Stryker Spine20196—
+3K190680Favo S-TlifSilony Medical GmbH20190—
+3K181096Avenue P Cage SystemZimmer Biomet Spine, Inc.20190—
+3K172816TiGer Shark™ SystemChoicespine, LP201859—
+3K172419Velofix™ TLIF CageU&I Corporation20172—
+3K171686Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) SystemChoicespine2017116—
+3K162760Spine Wave Anterior Cervical Spine SystemSpine Wave, Inc.20171—
+4K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+4K253401SCRIPT™ Implant SystemGlobus Medical, 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—
+4K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc.20251—
+4K251459OneLIF™ Interbody Fusion SystemNovapproach Spine, LLC20250—
+4K251335Tera Lumbar Interbody Fusion System (Various PNs)Acuity Surgical Devices, LLC20251—
+4K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—
+4K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+4K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+4K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+4K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+4K241477aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20246—
+4K241332aprevo® anterior and lateral lumbar interbody fusion device; aprevo® anterior lumbar…Carlsmed, Inc.20245—
+4K242509HAnano InterFuse (R) Modular InterbodyNext Orthosurgical20240—
+4K241328aprevo® Anterior and Lateral Lumbar Interbody Fusion device (ALIF/LLIF); aprevo®…Carlsmed, Inc.20240—
+4K241846E3D™-C Interbody SystemEvolution Spine20246—
+4K241413sagAlign Lumbar Cage System (Various PNs)Acuity Surgical Devices, LLC20240—
+4K241019aprevo® TLIF-C Articulating SystemCarlsmed20244—
+4K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody…Orthofix Medical, Inc.20242—
+4K241466Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System…SeaSpine Orthopedics Corporation20243—
+4K240749PILLAR SA Ti Spacer System (82-XXX)Orthofix, Inc.202402
+4K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+4K240623Omnia Medical TiBrid™-SA SystemOmnia Medical, LLC20240—
+4K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+4K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+4K232282aprevo® anterior and lateral lumbar interbody fusion device, aprevo® transforaminal…Carlsmed, Inc.20240—
+4K232432E3D™-A Interbody SystemEvolution Spine20248—
+4K231486Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20231—
+4K232530Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemNexus Spine, LLC20235—
+4K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+4K230851Kodiak Lumbar Spacer SystemMet One Technologies, LLC20230—
+4K231140aprevo® transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20236—
+4K221324ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF)Camber Spine Technologies20230—