510(k) Report

Devices descending from K020887

1,622 later devices reach Ebi Ais Spine System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K212612Omnia Medical TiBrid-SCOmnia Medical, LLC20220—
+7K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+7K221751NuVasive Cohere ALIF System Intervertebral Body Fusion DeviceNu Vasive, Incorporated20223—
+7K221447Southern Anterior Screw Fixated Cage (SASCA)Southern Medical (Pty), Ltd.20220—
+7K222561AlignAcuity Surgical Devices, LLC202214—
+7K220953ChoiceSpine TigerShark™ M, Modular Interbody SystemChoice Spine, LLC20220—
+7K220875HAcancellous PEEK-C Porous HA PEEK Cervical IBF SystemInnovasis, Inc.20224—
+7K221325CONDUIT Lateral Switch PlateMedos International SARL20221—
+7K221535Align Lumbar Interbody Fusion SystemAcuity Surgical Devices, LLC20223—
+7K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+7K212450Keos Anterior Cervical Interbody Fusion Device SystemKeos20220—
+7K220581Zavation eZspand Interbody SystemZavation Medical Products, LLC20224—
+7K220610SOLO-LAurora Spine, Inc.20220—
+7K221180Anteralign (TM) Spinal System with Titan NanoLOCK Surface Technology Navigated InstrumentsMedtronic Sofamor Danek USA, Inc.20222—
+7K220711SeaSpine Meridian System, SeaSpine Meridian Anterior Plate SystemSeaSpine Orthopedics Corporation202210—
+7K213420WaveForm L System, WaveForm TO System, WaveForm TA SystemSeaSpine Orthopedics Corporation202211—
+7K211837Altus Spine Interbody Standalone Fusion SystemAltus Partners, LLC20220—
+7K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+7K214047EL CAPITAN Anterior Lumbar Interbody Fusion SystemAstura Medical20223—
+7K213980Peridot Spinal Interbody SystemGbs Commonwealth Co., Ltd.20224—
+7K214011Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™ TL Spinal…Medtronic Sofamor Danek USA, Inc.20221—
+7K213951FORZA XP Expandable Spacer SystemOrthofix US, LLC20224—
+7K203714NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System…Nu Vasive, Incorporated202166—
+7K212715Vy Spine ClariVy Cervical IBF SystemVy Spine, LLC20216—
+7K213115CHENA-C Spacer SystemKahtnu Surgical, Inc.20210—
+7K212653Catalyft LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.202127
+7K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210—
+7K211805IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec…Alphatec Spine, Inc.202138—
+7K211689KEYSTONE PEEK Cage SystemShanghai Sanyou Medical Co, Ltd.20212—
+7K212540Explorer TO SystemSeaSpine Orthopedics Corporation20213—
+7K211449Triton™ Sacroiliac Joint Fixation SystemChoice Spine, LLC20211—
+7K210090Impulse AM Interbody Fusion SystemDegen Medical20217—
+7K211903Shoreline Threaded TruProfile® PlateSeaSpine Orthopedics Corporation20217—
+7K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+7K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+7K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+7K211442StealthStation Spinous Process ClampsMedtronic Navigation20212—
+7K210583SeaSpine WaveForm™ A Interbody SystemSeaSpine Orthopedics Corporation202114—
+7K211258Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA…Medtronic Sofamor Danek USA, Inc.202175—
+7K210425Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.2021561
+7K200919Idys ALIF 3DTiClariance20210—
+7K210271NuVasive Modulus ALIF SystemNu Vasive, Incorporated20215—
+7K210155Duo Expandable Interbody Fusion SystemSpineology, Inc.20210—
+7K202872Prase PEEK Anterior Cervical Interbody SpacerGbs Commonwealth Co., Ltd.20215—
+7K203531XYPAN Expandable Lumbar Cage SystemAegis Spine, Inc.20213—
+7K202298Lucent XP, Lucent XP CurvedSpinal Elements, Inc.20202—
+7K202820Australis Anterior Lumbar Cage SystemPrism Surgical Designs Pty, Ltd.20200—
+7K202587ATEC Lateral Interbody SystemAlphatec Spine, Inc.202039—
+7K200316UNiD IB3D ALIFMedicrea International SA20200—
+7K201506Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical…Meditech Spine, LLC20200—
+7K201087CORBEL SpacersGlobus Medical, Inc.202036—
+7K201605EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF Cage, EIT Cellular…Eit Emerging Implant Technologies GmbH2020130—
+7K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+7K200879SeaSpine Meridian System, SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation202060—
+7K200920Idys ALIF ZP 3DTiClariance, Sas20203—
+7K200991EVOL Spinal Interbody SystemCutting Edge Spine, LLC20200—
+7K200052CONSTRUX Mini PTC Spacer System, FORZA PTC Spacer System, PILLAR SA PTC Spacer SystemOrthofix, Inc.202013—
+7K200552EVOS Lumbar Interbody SystemCutting Edge Spine, LLC20200—
+7K193506NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR SystemNu Vasive, Incorporated20201—
+7K193255Largo PEEK Interbody SystemFlospine, LLC20201—
+7K193521Steerable Plateau TiLife Spine, Inc.20201—
+7K193258ProLift Expandable SystemLife Spine, Inc.20203—
+7K192115SABLE Expandable SpacerGlobus Medical, Inc.202037—
+7K191581Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion…Titan Spine, Inc.202081—
+7K1920444CIS Marlin PEEK ACIF CageSolco Biomedical Co., Ltd.20190—
+7K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+7K192248Cortina™ [MAX] Lumbar Cage SystemNeurostructures, Inc.20190—
+7K190721LongBow TiLife Spine, Inc.20190—
+7K192582NuVasive CoRoent Small Interlock SystemNu Vasive, Incorporated201930—
+7K192168Idys ALIF ZP 3DTiClariance, Sas20195—
+7K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+7K191584FORTICO Anterior Cervical Fixation SystemCamber Spine Technologies, LLC20192—
+7K191066CD Horizon™ Astute™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201921—
+7K191391HEDRON Lumbar SpacersGlobus Medical, Inc.201984—
+7K183407Triton CageMedyssey USA, Inc.20190—
+7K192054Endoskeleton TAS PlateTitan Spine, Inc.20190—
+7K191039Navigated T2 STRATOSPHERE Inserters and Navigated TemplatesMedtronic Sofamor Danek USA, Inc.201918—
+7K192047Rampart™ One Lumbar Interbody Fusion SystemSpineology, Inc.20190—
+7K183249Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved…Stryker Spine20196—
+7K190680Favo S-TlifSilony Medical GmbH20190—
+7K182158UNiD Patient-matched PLIF cageMedicrea International SA201921—
+7K190959ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2019108—
+7K183064TxTi IBF SystemInnovasis, Inc.2019481
+7K190684LxHA PEEK Lateral IBF SystemInnovasis, Inc.20190—
+7K182608Oyster ACIF CageSilony Medical GmbH20190—
+7K191263Idys ALIF TiVacClariance, Sas20190—
+7K190877Juliet® Ti LL Lumbar Interbody DeviceSpineart201911
+7K190147COLOSSEUM MeshGlobus Medical, Inc.20190—
+7K190092UNiD Patient specific 3D printed TLIF cageMedicrea International SA201913—
+7K190655SeaSpine® Shoreline™ ACS- Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation201974—
+7K183588Choice Spine Hawkeye Vertebral Body Replacement (VBR) SystemChoicespine20195—
+7K182284Tyber Medical PT Interbody SpacerTyber Medical, LLC20195—
+7K181899Roccia® PlifSilony Medical GmbH20180—
+7K181625Life Spine Resolute™ Threaded Cage SystemLife Spine, Inc.20180—
+7K180665SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage SystemK2m, LLC20189—
+7K182470Plateau Spacer SystemLife Spine20180—
+7K181921Solidity Vertebral Body ReplacementUlrich Medical USA20182—
+7K181644EIT Cellular Titanium® Lumbar Cage LLIFEit Emerging Implant Technologies GmbH2018141—
+7K181818Scarlet AL-TSpineart201864—
+7K181531SpineEX Sagittae Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20183—