510(k) Report

Devices descending from K080728

903 later devices reach LDR Spine Roi-C Implant through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+7K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+7K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+7K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+7K233694Meridian Interbody System; WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20248—
+7K230872Halis™ Lumbar Cage System, Lydia™ Anterior Lumbar Fusion System, Dica™ Direction…Shanghai Sanyou Medical Co, Ltd.20231—
+7K230639Align Cervical Interbody Fusion SystemAcuity Surgical Devices, LLC20232—
+7K233084Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT…Gbs Commonwealth Co., Ltd.20232—
+7K232345ATEC Posterior Navigated Disc Prep InstrumentsAlphatec Spine, Inc.20232—
+7K231899HAtetracell™-C Titanium Cervical IBF SystemInnovasis, Inc.20232—
+7K232822Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system), Anterior…Gbs Commonwealth Co., Ltd.20232—
+7K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+7K231147Hammerdesis™ Interphalangeal Fusion SystemIntelivation20230—
+7K232154MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate FixationMiRus, LLC20230—
+7K232150ZSFab Cervical Interbody SystemZsfab, Inc.20234—
+7K231275Exceed™ Biplanar Expandable Interbody SystemSpine Wave, Inc.20232—
+7K231808QUASAR Standalone ACIF SystemGS Medical Co., Ltd.20230—
+7K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+7K231241NanoHive Medical Lumbar Interbody SystemNanoHive Medical, LLC20230—
+7K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+7K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+7K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+7K223418DeGen Impulse AM™ SystemDegen Medical20236—
+7K223688CONDUIT™ Lateral Lumbar Intervertebral Fusion Cage, CONDUIT™ InstrumentsMedos International Sàrl20230—
+7K223174X-Pac Expandable LLIF Cage SystemExpanding Innovations, Inc.20233—
+7K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+7K223494CD Horizon Spinal SystemMedtronic202317—
+7K223140AEON-C™ Stand Alone SystemDio Medical, Inc.20222—
+7K2136534CIS Black Marlin Plif Cage System, 4CIS Dolphin Tlif Cage SystemSolco Biomedical Company India Private Limited20220—
+7K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—
+7K222732WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20229—
+7K221162UniVy OsteoVy Cervical IBF SystemVy Spine, LLC20222—
+7K221545MectaLIF Anterior ExtensionMedacta International S.A.202226
+7K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+7K222276CONDUIT Cages; FIBERGRAFT BG PuttyDepuy Spine202229—
+7K221858ZSFab Lumbar Interbody SystemZsfab, Inc.20224—
+7K221172FOCUS Interbody SystemOc Medical Devices20220—
+7K221646CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™…Medtronic Sofamor Danek USA, Inc.202220—
+7K221325CONDUIT Lateral Switch PlateMedos International SARL20221—
+7K220696uCerv Flux-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA20221—
+7K220449DePuy CONDUIT LLIF SQUID InserterEnztec Limited20220—
+7K220523restor3d TiDAL Lumbar Interbody Fusion DeviceRestor3D20222—
+7K220115ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion SystemMiRus, LLC20220—
+7K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+7K213355Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20224—
+7K213980Peridot Spinal Interbody SystemGbs Commonwealth Co., Ltd.20224—
+7K211320CAPRI Corpectomy Cage SystemK2m, Inc.20222—
+7K214011Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™ TL Spinal…Medtronic Sofamor Danek USA, Inc.20221—
+7K212980Tesera-k ALIF SystemKyocera Medical Technologies, Inc.20222—
+7K213951FORZA XP Expandable Spacer SystemOrthofix US, LLC20224—
+7K212715Vy Spine ClariVy Cervical IBF SystemVy Spine, LLC20216—
+7K212524Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.202155—
+7K212823DePuy CONDUIT LLIF Angled InsertersEnztec Limited20213—
+7K211689KEYSTONE PEEK Cage SystemShanghai Sanyou Medical Co, Ltd.20212—
+7K211903Shoreline Threaded TruProfile® PlateSeaSpine Orthopedics Corporation20217—
+7K212070KMTI S141 Lumbar Interbody Fusion SystemKyocera Medical Technologies, Inc.20210—
+7K210800IO Expandable Lumbar Interbody Fusion SystemMiRus, LLC20212—
+7K211205Prase-C Anterior Cervical Plate SystemGbs Commonwealth Co., Ltd.20210—
+7K203003Pantheon IBFDPantheon Spinal20210—
+7K210214NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody SystemNu Vasive, Incorporated20213—
+7K210728CONDUIT InstrumentsMedos International SARL20215—
+7K201671A-Link ZAcuity Surgical Devices, LLC202125—
+7K200919Idys ALIF 3DTiClariance20210—
+7K202032Idys LLIF 3DTiClariance, Sas20210—
+7K210155Duo Expandable Interbody Fusion SystemSpineology, Inc.20210—
+7K202488ZSFab Cervical Interbody SystemZsfab, Inc.20216—
+7K202637F3D Corpectomy SystemCorelink, LLC20201—
+7K202820Australis Anterior Lumbar Cage SystemPrism Surgical Designs Pty, Ltd.20200—
+7K200316UNiD IB3D ALIFMedicrea International SA20200—
+7K201500Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar SpacerLife Spine, Inc.20203—
+7K200920Idys ALIF ZP 3DTiClariance, Sas20203—
+7K200235KONG-TL VBR System, KONG-C VBR SystemIcotec AG20201—
+7K200541Hive™ Stand-alone Anterior Lumbar Interbody SystemHd Lifesciences, LLC20201—
+7K192145Galileo Vertebral Body Replacement DeviceBright Spine20201—
+7K200613Tritanium® X TL Expandable Curved Posterior Lumbar CageStryker Corporation20205—
+7K200052CONSTRUX Mini PTC Spacer System, FORZA PTC Spacer System, PILLAR SA PTC Spacer SystemOrthofix, Inc.202013—
+7K200048MectaLIF Anterior SimpleMedacta International S.A.20200—
+7K193412NEXXT MATRIXX SystemNexxt Spine, LLC20201—
+7K192497EVOL ha - D Lateral Interbody Fusion SystemCutting Edge Spine, LLC20201—
+7K192582NuVasive CoRoent Small Interlock SystemNu Vasive, Incorporated201930—
+7K192168Idys ALIF ZP 3DTiClariance, Sas20195—
+7K192117Small VBR™Ulrich GmbH & Co. KG20196—
+7K191039Navigated T2 STRATOSPHERE Inserters and Navigated TemplatesMedtronic Sofamor Danek USA, Inc.201918—
+7K191311ATEC Lateral Interbody SystemAlphatec Spine, Inc.201978—
+7K191423Normandy VBR SystemZavation Medical Products, LLC20193—
+7K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+7K191263Idys ALIF TiVacClariance, Sas20190—
+7K183184FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.201912—
+7K183426MectaLIF Anterior Stand Alone ExtensionMedacta International S.A.20191—
+7K182920MiRus™ Lumbar Interbody Fusion System consisting of CALLISTO™ PEEK Posterior Lumbar…MiRus, LLC20199—
+7K183510T2 STRATOSPHERE Expandable Corpectomy SystemMedtronic Sofamor Danek USA, Inc.201927—
+7K181589Curiteva Lumbar Interbody Fusion SystemCuriteva, LLC20186—
+7K180891EVOL Spinal Interbody System, EVOS Lumbar Interbody SystemCutting Edge Spine, LLC20181—
+7K173030Vertera Spine Cohere Cervical Interbody Fusion DeviceNu Vasive, Incorporated201722—
+7K172392Lateral Spinal Truss System (LSTS) Interbody Fusion Device4Web, Inc.20171—
+7K171351Posterior Spine Truss System (PSTS) Interbody Fusion Device4Web, Inc.20177—
+7K172489Reliance Cervical IBF SystemReliance Medical Systems, LLC201716—
+7K171140Matrixx SystemNexxt Spine, LLC2017145—
+7K171749Velofix (tm) Interbody Fusion SystemU&I Corporation20175—
+7K170399Endoskeleton TO Interbody Fusion Device (IBD)Titan Spine, LLC2017105—