510(k) Report

Devices descending from K090064

701 later devices reach Eminent Spine Interbody Fusion System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K253545Vulcan Spinal SystemK2m, Inc.20260—
+6K252711Advantage-C™ Ti3D Cervical Interbody Fusion DeviceIntelivation Technologies20260—
+6K253577IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)Medicrea International S.A.S. (Medtronic)20250—
+6K252610ZSFab Lumbar Interbody SystemZsfab, Inc.20251—
+6K252686EffortMed PEEK Cages & Corpectomy CagesEffortmed, LLC20251—
+6K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+6K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+6K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+6K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+6K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+6K250987aprevo® posterior/transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20251—
+6K243816Testa TP Pivoting Spacer SystemSpine Wave, Inc.20250—
+6K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+6K250603AxTiHA® Stand-Alone ALIF SystemInnovasis20250—
+6K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—
+6K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+6K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+6K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+6K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+6K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+6K242589Scarlet® AL-TSpineart SA20240—
+6K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+6K232996Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF)Shanghai Iatrical-Ti Technologies CO, Ltd.20240—
+6K241738PYXIS 3D Titanium Cervical Cage systemGS Medical Co., Ltd.20241—
+6K241321Juliet® Ti LL Lumbar Interbody DeviceSpineart SA20240—
+6K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+6K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+6K230639Align Cervical Interbody Fusion SystemAcuity Surgical Devices, LLC20232—
+6K232348RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion SystemMiRus, LLC20231—
+6K232822Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system), Anterior…Gbs Commonwealth Co., Ltd.20232—
+6K231241NanoHive Medical Lumbar Interbody SystemNanoHive Medical, LLC20230—
+6K230894NuVasive Modulus ALIF SystemNu Vasive, Incorporated20234—
+6K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+6K230851Kodiak Lumbar Spacer SystemMet One Technologies, LLC20230—
+6K223868PYXIS 3D Titanium Cage SystemGS Medical Co., Ltd.20232—
+6K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+6K230583Tryptik TiSpineart SA20231—
+6K223174X-Pac Expandable LLIF Cage SystemExpanding Innovations, Inc.20233—
+6K223140AEON-C™ Stand Alone SystemDio Medical, Inc.20222—
+6K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—
+6K221545MectaLIF Anterior ExtensionMedacta International S.A.202226
+6K221858ZSFab Lumbar Interbody SystemZsfab, Inc.20224—
+6K221447Southern Anterior Screw Fixated Cage (SASCA)Southern Medical (Pty), Ltd.20220—
+6K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+6K220875HAcancellous PEEK-C Porous HA PEEK Cervical IBF SystemInnovasis, Inc.20224—
+6K221325CONDUIT Lateral Switch PlateMedos International SARL20221—
+6K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+6K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+6K213420WaveForm L System, WaveForm TO System, WaveForm TA SystemSeaSpine Orthopedics Corporation202211—
+6K214010Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA202249—
+6K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC20223—
+6K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+6K211320CAPRI Corpectomy Cage SystemK2m, Inc.20222—
+6K212980Tesera-k ALIF SystemKyocera Medical Technologies, Inc.20222—
+6K203714NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System…Nu Vasive, Incorporated202166—
+6K211474Kleiner KG2 SystemBAAT Medical Products B.V.20210—
+6K210470C-CURVE Interbody Fusion DeviceMedicrea International SA20210—
+6K211704CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini PTC Spacer…Orthofix, Inc.20215—
+6K210090Impulse AM Interbody Fusion SystemDegen Medical20217—
+6K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+6K210521DEXA-C Cervical Interbody SystemAurora Spine, Inc.20210—
+6K203003Pantheon IBFDPantheon Spinal20210—
+6K210542aprevo Transforaminal IBFCarlsmed, Inc.202112—
+6K210583SeaSpine WaveForm™ A Interbody SystemSeaSpine Orthopedics Corporation202114—
+6K211258Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA…Medtronic Sofamor Danek USA, Inc.202175—
+6K210425Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.2021561
+6K200919Idys ALIF 3DTiClariance20210—
+6K210359Hexanium TLIFSpinevision, S.A.S.20211—
+6K210271NuVasive Modulus ALIF SystemNu Vasive, Incorporated20215—
+6K210155Duo Expandable Interbody Fusion SystemSpineology, Inc.20210—
+6K203683CarboClear Lumbar Cage SystemCarbofix Orthpedics, Ltd.20211—
+6K203201NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated202194—
+6K202637F3D Corpectomy SystemCorelink, LLC20201—
+6K201287Impulse Interbody Fusion SystemDegen Medical20208—
+6K202034aprevo Intervertebral Body Fusion DeviceCarlsmed, Inc.202017—
+6K203076Mecta-C Stand Alone ExtensionMedacta International S.A.20200—
+6K200316UNiD IB3D ALIFMedicrea International SA20200—
+6K202065DOLOMITE Anterior Cervical Stabilization SystemAstura Medical, LLC20203—
+6K202305Zavation IBF SystemZavation Medical Products, LLC20209—
+6K201453Fortilink Cages with TiPlus TechnologyParadigm Spine GmbH20204—
+6K200953NuVasive® Cohere® Thoracolumbar Interbody SystemNu Vasive, Incorporated2020141—
+6K201820NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated2020156—
+6K201073Seaspine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202017—
+6K201267Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek202079—
+6K201500Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar SpacerLife Spine, Inc.20203—
+6K201605EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF Cage, EIT Cellular…Eit Emerging Implant Technologies GmbH2020130—
+6K200235KONG-TL VBR System, KONG-C VBR SystemIcotec AG20201—
+6K200920Idys ALIF ZP 3DTiClariance, Sas20203—
+6K200969NEXXT MATRIXX SystemNexxt Spine, LLC20200—
+6K191906MiRus 3D Printed Lumbar Interbody Fusion Systems consisting of the Callisto 3D Printed…MiRus, LLC20206—
+6K192145Galileo Vertebral Body Replacement DeviceBright Spine20201—
+6K192897icotec Cervical CageIcotec AG20201—
+6K200048MectaLIF Anterior SimpleMedacta International S.A.20200—
+6K192906Mecta-C Stand AloneMedacta International S.A.20201—
+6K193506NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR SystemNu Vasive, Incorporated20201—
+6K193412NEXXT MATRIXX SystemNexxt Spine, LLC20201—
+6K192993Scarlet AL-TSpineart20201—
+6K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+6K193370Nexxt Matrixx SystemNexxt Spine, LLC20202—
+6K192687TrellOss™-L MPFNexxt Spine, LLC20201—