510(k) Report

Devices descending from K022793

1,705 later devices reach Tetris Spinal Implant through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K221751NuVasive Cohere ALIF System Intervertebral Body Fusion DeviceNu Vasive, Incorporated20223—
+7K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+7K211785CASSATT™ SIJ Fixation SystemCtl Medical Corporation20220—
+7K221172FOCUS Interbody SystemOc Medical Devices20220—
+7K221858ZSFab Lumbar Interbody SystemZsfab, Inc.20224—
+7K222561AlignAcuity Surgical Devices, LLC202214—
+7K220875HAcancellous PEEK-C Porous HA PEEK Cervical IBF SystemInnovasis, Inc.20224—
+7K220696uCerv Flux-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA20221—
+7K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+7K220478NuVasive MOD-EX XLIF Interbody System, NuVasive MOD-EX XLIF Plated 2.0 Interbody SystemNu Vasive, Incorporated20222—
+7K212450Keos Anterior Cervical Interbody Fusion Device SystemKeos20220—
+7K220581Zavation eZspand Interbody SystemZavation Medical Products, LLC20224—
+7K220610SOLO-LAurora Spine, Inc.20220—
+7K214010Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA202249—
+7K214047EL CAPITAN Anterior Lumbar Interbody Fusion SystemAstura Medical20223—
+7K213355Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20224—
+7K213980Peridot Spinal Interbody SystemGbs Commonwealth Co., Ltd.20224—
+7K203714NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System…Nu Vasive, Incorporated202166—
+7K212715Vy Spine ClariVy Cervical IBF SystemVy Spine, LLC20216—
+7K212524Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.202155—
+7K213115CHENA-C Spacer SystemKahtnu Surgical, Inc.20210—
+7K212653Catalyft LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.202127
+7K211845Deploy Expandable Interbody SystemSouthern Spine, LLC20210—
+7K212520ProLift Micro Expandable Spacer SystemLife Spine, Inc.20216—
+7K210590Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20210—
+7K211805IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec…Alphatec Spine, Inc.202138—
+7K211689KEYSTONE PEEK Cage SystemShanghai Sanyou Medical Co, Ltd.20212—
+7K211474Kleiner KG2 SystemBAAT Medical Products B.V.20210—
+7K210470C-CURVE Interbody Fusion DeviceMedicrea International SA20210—
+7K211704CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini PTC Spacer…Orthofix, Inc.20215—
+7K212070KMTI S141 Lumbar Interbody Fusion SystemKyocera Medical Technologies, Inc.20210—
+7K211903Shoreline Threaded TruProfile® PlateSeaSpine Orthopedics Corporation20217—
+7K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+7K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+7K210595SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar SpacersCamber Spine Technologies, LLC20213—
+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
+7K210439NuVasive MOD-EX XLIF Interbody SystemNu Vasive, Incorporated20214—
+7K210061ProLift Lateral HELO FixatedLife Spine, Inc.20213—
+7K200919Idys ALIF 3DTiClariance20210—
+7K203361ProLift Wedge Expandable Spacer SystemLife Spine, Inc.20211—
+7K210359Hexanium TLIFSpinevision, S.A.S.20211—
+7K202380Born PT-LIF Cage HASpineworxx AG20210—
+7K210155Duo Expandable Interbody Fusion SystemSpineology, Inc.20210—
+7K202872Prase PEEK Anterior Cervical Interbody SpacerGbs Commonwealth Co., Ltd.20215—
+7K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc.202135—
+7K203201NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated202194—
+7K202488ZSFab Cervical Interbody SystemZsfab, Inc.20216—
+7K202820Australis Anterior Lumbar Cage SystemPrism Surgical Designs Pty, Ltd.20200—
+7K202230NEXXT MATRIXX Stand Alone ALIF SystemNexxt Spine, LLC20200—
+7K202587ATEC Lateral Interbody SystemAlphatec Spine, Inc.202039—
+7K201692NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated202067—
+7K201820NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated2020156—
+7K201721TruLift Expandable Spacer SystemLife Spine, Inc.20205—
+7K200958MODULIF-A Anterior Lumbar Interbody Fusion SystemSpinal Stability, LLC20200—
+7K201267Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek202079—
+7K201500Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar SpacerLife Spine, Inc.20203—
+7K201087CORBEL SpacersGlobus Medical, Inc.202036—
+7K201605EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF Cage, EIT Cellular…Eit Emerging Implant Technologies GmbH2020130—
+7K201614TxTiHA IBF System, AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.2020471
+7K193172Luna XD Ti Interbody Fusion SystemBenvenue Medical, Inc.20201—
+7K200920Idys ALIF ZP 3DTiClariance, Sas20203—
+7K200969NEXXT MATRIXX SystemNexxt Spine, LLC20200—
+7K200352Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20202—
+7K191906MiRus 3D Printed Lumbar Interbody Fusion Systems consisting of the Callisto 3D Printed…MiRus, LLC20206—
+7K200991EVOL Spinal Interbody SystemCutting Edge Spine, LLC20200—
+7K192145Galileo Vertebral Body Replacement DeviceBright Spine20201—
+7K200338ProLift Lateral FixatedLife Spine, Inc.20205—
+7K200552EVOS Lumbar Interbody SystemCutting Edge Spine, LLC20200—
+7K193593NuVasive 3DP Interfixated ALIF SystemNu Vasive, Incorporated2020157—
+7K191788CAPSTONE Spinal System, CLYDESDALE PTC Spinal System, CRESCENT Spinal System, CRESCENT…Medtronic Sofamor Danek USA, Inc.20200—
+7K193203MOJAVE Expandable Interbody SystemK2m, Inc.202015—
+7K193320KMTI Tesera SA Anterior Lumbar Interbody Fusion (ALIF) SystemKyocera Medical Technologies, Inc.20203—
+7K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20206—
+7K193370Nexxt Matrixx SystemNexxt Spine, LLC20202—
+7K192115SABLE Expandable SpacerGlobus Medical, Inc.202037—
+7K192687TrellOss™-L MPFNexxt Spine, LLC20201—
+7K191581Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion…Titan Spine, Inc.202081—
+7K191834Stand-Alone ALIF Titanium SystemLife Spine, Inc.20190—
+7K191796Neo Cage SystemNeo Medical SA20190—
+7K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+7K192582NuVasive CoRoent Small Interlock SystemNu Vasive, Incorporated201930—
+7K191477AEON-C Stand Alone SystemHuvexel Co., Ltd.201910—
+7K192168Idys ALIF ZP 3DTiClariance, Sas20195—
+7K191134IB3D AlifMedicrea International SA20191—
+7K191584FORTICO Anterior Cervical Fixation SystemCamber Spine Technologies, LLC20192—
+7K192760NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2019163—
+7K191066CD Horizon™ Astute™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201921—
+7K191391HEDRON Lumbar SpacersGlobus Medical, Inc.201984—
+7K190708AccelFix Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20195—
+7K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc.20196—
+7K191423Normandy VBR SystemZavation Medical Products, LLC20193—
+7K183249Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved…Stryker Spine20196—
+7K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+7K190488ProLift Expandable SystemLife Spine, Inc.201916—
+7K182158UNiD Patient-matched PLIF cageMedicrea International SA201921—
+7K191408Nexxt Matrixx SystemNexxt Spine, LLC20190—
+7K190959ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2019108—
+7K182608Oyster ACIF CageSilony Medical GmbH20190—
+7K191005ProLift® Expandable SystemLife Spine, Inc.201918—