510(k) Report

Devices descending from K110933

185 later devices reach Spineology Peek Lumbar Interbody Fusion Device through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K151020Rampart-T Interbody Fusion SystemSpineology, Inc.20151—
+1K120293Spineology Peek Lumbar Interbody Fusion DriveSpineology, Inc.2012184—
+2K163409Rampart (TM) T Lumbar Interbody Fusion DeviceSpineology, Inc.20170—
+2K133371Rampart-LSpineology, Inc.20147—
+2K131216Rampart OSpineology, Inc.2013180—
+2K130396Rampart O and Rampart PSpineology, Inc.2013181—
+2K123652Spineology Peek Lumbar Interbody Fusion DeviceSpineology, Inc.2013181—
+2K121129Spineology Peek Lumbar Interbody Fusion DeviceSpineology, Inc.2012180—
+3K171724Rampart L Lumbar Interbody Fusion DeviceSpineology, Inc.20170—
+3K160074Rampart D Lumbar Interbody Fusion DeviceSpineology, Inc.20165—
+3K153082Rampart A Lumbar Interbody Fusion DeviceSpineology, Inc.201628—
+3K132053Rampart-O, Rampart-TSpineology, Inc.2013179—
+4K171660Duo Lumbar Interbody Fusion DeviceSpineology, Inc.20174—
+4K171031CRESCENT™ Spinal SystemMedtronic Sofamor Danek2017144—
+4K163670Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20173—
+4K160906Rampart O Lumbar Interbody Fusion Device, Rampart T Lumbar Interbody Fusion Device…Spineology, Inc.201627—
+5K223153Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.20220—
+5K210425Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.2021561
+5K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+5K181357PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc.201897—
+5K181792Duo™ Lumbar Interbody Fusion DeviceSpineology, Inc.20183—
+5K180002Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20182—
+5K170643Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) SystemRti Surgical, Inc. Dba Rti Biologics201711—
+5K162879Elite Expandable Interbody Fusion DeviceSpineology, Inc.20179—
+6K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+6K241164IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic)202412
+6K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+6K214011Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™ TL Spinal…Medtronic Sofamor Danek USA, Inc.20221—
+6K212524Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.202155—
+6K192115SABLE Expandable SpacerGlobus Medical, Inc.202037—
+6K191391HEDRON Lumbar SpacersGlobus Medical, Inc.201984—
+6K191091Rampart One Lumbar Interbody Fusion SystemSpineology, Inc.20191—
+6K190055Duo Lumbar Interbody Fusion DeviceSpineology, Inc.20191—
+6K182322Duo Lumbar Interbody Fusion DeviceSpineology, Inc.20182—
+6K172343Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D TechnologyRti Surgical, Inc.201710—
+6K171425Concorde LiftMedos International SARL201782
+7K261049Scala® TLSpineart SA20260—
+7K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+7K260837VersaLift Expandable SystemLife Spine, Inc.20260—
+7K253260ORIO-3D Cage SystemSpineCraft20260—
+7K253577IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)Medicrea International S.A.S. (Medtronic)20250—
+7K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting20250—
+7K233947KLIMT™ Expandable Lumbar Interbody Fusion (LIF) Cage SystemCtl Medical Corporation20240—
+7K233807LumiVy™ Lumbar IBF SystemVy Spine, LLC20241—
+7K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+7K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+7K240368E3D™-A Interbody SystemEvolution Spine20247—
+7K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+7K230894NuVasive Modulus ALIF SystemNu Vasive, Incorporated20234—
+7K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+7K223146EVOLUTION SPINE Interbody SystemEvolution Spine20239—
+7K222009aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.202212—
+7K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+7K221936Standalone ALIF Interbody Fusion SystemEminent Spine20222—
+7K222383Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX Stealth (TM)…Medtronic Sofamor Danek USA, Inc.20220—
+7K222082aprevo® anterior and lateral lumbar interbody fusion devices, aprevo® transforaminal…Carlsmed, Inc.202211—
+7K220581Zavation eZspand Interbody SystemZavation Medical Products, LLC20224—
+7K221180Anteralign (TM) Spinal System with Titan NanoLOCK Surface Technology Navigated InstrumentsMedtronic Sofamor Danek USA, Inc.20222—
+7K220115ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion SystemMiRus, LLC20220—
+7K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+7K214010Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA202249—
+7K213493Fortilink with TiPlus TechnologyParadigm Spine20220—
+7K210800IO Expandable Lumbar Interbody Fusion SystemMiRus, LLC20212—
+7K210595SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar SpacersCamber Spine Technologies, LLC20213—
+7K210214NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody SystemNu Vasive, Incorporated20213—
+7K201671A-Link ZAcuity Surgical Devices, LLC202125—
+7K210155Duo Expandable Interbody Fusion SystemSpineology, Inc.20210—
+7K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc.202135—
+7K202034aprevo Intervertebral Body Fusion DeviceCarlsmed, Inc.202017—
+7K201087CORBEL SpacersGlobus Medical, Inc.202036—
+7K190708AccelFix Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20195—
+7K192047Rampart™ One Lumbar Interbody Fusion SystemSpineology, Inc.20190—
+7K190498Fortilink® IBF System with TETRAfuse®3D Technology, include the following designs…Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20197—
+7K182349Concorde LiftMedos International SARL20190—
+7K173537Concorde Lift™Medos International SARL20181—
+8K261408SABER-XA SystemElevation Spine20260—
+8K260810Anteralign LS coverplateTyber Medical, LLC20260—
+8K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+8K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+8K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+8K252742Navigated InstrumentsTyber Medical, LLC20251—
+8K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+8K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+8K243386Ventris Intervertebral Body Fusion DeviceAcuity Surgical Devices, LLC20252—
+8K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+8K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+8K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+8K241477aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20246—
+8K241332aprevo® anterior and lateral lumbar interbody fusion device; aprevo® anterior lumbar…Carlsmed, Inc.20245—
+8K241328aprevo® Anterior and Lateral Lumbar Interbody Fusion device (ALIF/LLIF); aprevo®…Carlsmed, Inc.20240—
+8K241846E3D™-C Interbody SystemEvolution Spine20246—
+8K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+8K241019aprevo® TLIF-C Articulating SystemCarlsmed20244—
+8K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+8K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+8K232282aprevo® anterior and lateral lumbar interbody fusion device, aprevo® transforaminal…Carlsmed, Inc.20240—
+8K232432E3D™-A Interbody SystemEvolution Spine20248—
+8K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+8K233694Meridian Interbody System; WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20248—
+8K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—