510(k) Report

Devices descending from K031757

1,702 later devices reach Peek Tetris Spinal Implant through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K202820Australis Anterior Lumbar Cage SystemPrism Surgical Designs Pty, Ltd.20200—
+6K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc.202067—
+6K201755WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody SystemSeaSpine Orthopedics Corporation202017—
+6K202587ATEC Lateral Interbody SystemAlphatec Spine, Inc.202039—
+6K203076Mecta-C Stand Alone ExtensionMedacta International S.A.20200—
+6K202949CONSTRUX Mini PEEK Spacer SystemOrthofix, Inc.20206—
+6K200084Zavation IBF SystemZavation Medical Products, LLC20208—
+6K202666CONSTRUX Mini PTC Spacer SystemOrthofix, Inc.202010—
+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—
+6K200115Cavetto-SA Cervical Cage SystemNeurostructures, Inc.202019—
+6K201506Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical…Meditech Spine, LLC20200—
+6K200958MODULIF-A Anterior Lumbar Interbody Fusion SystemSpinal Stability, LLC20200—
+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—
+6K193172Luna XD Ti Interbody Fusion SystemBenvenue Medical, Inc.20201—
+6K200920Idys ALIF ZP 3DTiClariance, Sas20203—
+6K200969NEXXT MATRIXX SystemNexxt Spine, LLC20200—
+6K200352Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20202—
+6K191906MiRus 3D Printed Lumbar Interbody Fusion Systems consisting of the Callisto 3D Printed…MiRus, LLC20206—
+6K200541Hive™ Stand-alone Anterior Lumbar Interbody SystemHd Lifesciences, LLC20201—
+6K193636SeaSpine Reef TH SystemSeaSpine Orthopedics Corporation202056—
+6K192492EL CAPITAN Anterior Lumber Interbody SystemAstura Medical, LLC202010—
+6K192145Galileo Vertebral Body Replacement DeviceBright Spine20201—
+6K193541NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2020157—
+6K191788CAPSTONE Spinal System, CLYDESDALE PTC Spinal System, CRESCENT Spinal System, CRESCENT…Medtronic Sofamor Danek USA, Inc.20200—
+6K193203MOJAVE Expandable Interbody SystemK2m, Inc.202015—
+6K193320KMTI Tesera SA Anterior Lumbar Interbody Fusion (ALIF) SystemKyocera Medical Technologies, Inc.20203—
+6K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20206—
+6K192993Scarlet AL-TSpineart20201—
+6K193370Nexxt Matrixx SystemNexxt Spine, LLC20202—
+6K192687TrellOss™-L MPFNexxt Spine, LLC20201—
+6K191581Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion…Titan Spine, Inc.202081—
+6K192497EVOL ha - D Lateral Interbody Fusion SystemCutting Edge Spine, LLC20201—
+6K191834Stand-Alone ALIF Titanium SystemLife Spine, Inc.20190—
+6K191796Neo Cage SystemNeo Medical SA20190—
+6K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+6K191477AEON-C Stand Alone SystemHuvexel Co., Ltd.201910—
+6K192168Idys ALIF ZP 3DTiClariance, Sas20195—
+6K191134IB3D AlifMedicrea International SA20191—
+6K192434DualX Lumbar Intervertebral Body Fusion DeviceAmplify Surgical, Inc.20190—
+6K192214CarboClear VBR SystemCarboFix Orthopedics, Ltd.20191—
+6K192208CORNICE Cervical Spacer SystemLegend Spine Technologies20190—
+6K191243HEDRON Cervical SpacersGlobus Medical, Inc.201936—
+6K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc.20196—
+6K191339Zavation eZspand Interbody SystemZavation Medical Products, LLC20195—
+6K190885Elevation Spine Saber-C SystemElevation Spine201925—
+6K191423Normandy VBR SystemZavation Medical Products, LLC20193—
+6K190291Addivation Medical Cervical Interbody SystemAddivation Medical, LLC20190—
+6K190680Favo S-TlifSilony Medical GmbH20190—
+6K183243Velofix TLIF CageU&I Corporation20190—
+6K191408Nexxt Matrixx SystemNexxt Spine, LLC20190—
+6K182139AXTi Titanium Stand-Alone ALIF SystemInnovasis, Inc.201972—
+6K182608Oyster ACIF CageSilony Medical GmbH20190—
+6K191263Idys ALIF TiVacClariance, Sas20190—
+6K190877Juliet® Ti LL Lumbar Interbody DeviceSpineart201911
+6K190165Capstone Control™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20196—
+6K182877HALF DOME Posterior Lumbar Interbody SystemAstura Medical, LLC201921—
+6K183426MectaLIF Anterior Stand Alone ExtensionMedacta International S.A.20191—
+6K190322SCARLET® AC-T Secured Anterior Cervical CageSpineart20191—
+6K182885Atlantis™ Anterior Cervical Plate, Divergence™ Anterior Cervical Fusion System, Premier™…Medtronic Sofamor Danek USA, Inc.20198—
+6K181048Neo Cage System TMNeo Medical SA20191—
+6K180822VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion SystemWenzel Spine, Inc.20195—
+6K180230NEST Interbody SystemPaonan Biotech Co., Ltd.20191—
+6K183510T2 STRATOSPHERE Expandable Corpectomy SystemMedtronic Sofamor Danek USA, Inc.201927—
+6K181096Avenue P Cage SystemZimmer Biomet Spine, Inc.20190—
+6K180228II-Type Intervertebral SpacerPaonan Biotech Co., Ltd.20191—
+6K181118Reliance Lumbar IBF SystemReliance Medical Systems20190—
+6K180909REVEL SpacersGlobus Medical, Inc.201837—
+6K181357PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc.201897—
+6K181140Axis Chena Cervical PEEK Spacer SystemAxis Orthopaedics20182—
+6K181829Velofix TLIF CageU&I Corporation20181—
+6K182322Duo Lumbar Interbody Fusion DeviceSpineology, Inc.20182—
+6K181644EIT Cellular Titanium® Lumbar Cage LLIFEit Emerging Implant Technologies GmbH2018141—
+6K180215DYNA-LINK ELITE Stand-Alone Anterior Lumbar SystemLife Spine, Inc.20182—
+6K181655Renovis S180 Lateral Lumbar Interbody Fusion SystemRenovis Surgical Technologies20184—
+6K173893TrabisColigne AG20180—
+6K181386NuVasive Brigade Lateral SystemNu Vasive, Incorporated2018158—
+6K180373CancelleX Porous Titanium Lumbar Interbody DeviceXenco Medical, LLC20180—
+6K181435ATEC Cervical Spacer SystemAlphatec Spine, Inc.2018100—
+6K180990TirboLOX-L Lumbar IBFDCaptiva Spine, Inc.20181—
+6K180777K2M Expandable Interbody SystemK2m, Inc.20180—
+6K180695FBC 921 (Alif)Fbc Device Aps20180—
+6K180963Roccia Alif, Roccia TlifSilony Medical GmbH20183—
+6K180364HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC2018106—
+6K180502S128 Anterior Lumbar Interbody Fusion (ALIF) SystemRenovis Surgical Technologies, Inc.201811—
+6K180401TiWAVE-C™ Porous Titanium Cervical CageKalitec Direct, LLC20185—
+6K173722PATRIOT COLONIAL Spacer, SUSTAIN SpacerGlobus Medical, Inc.201894—
+6K173832InTice™-C Porous Ti Cervical Interbody SystemX-Spine Systems, Inc.201801
+6K172568CervagePrecifit Medical, Ltd.20181—
+6K173892NuVasive® XLX Interbody SystemNu Vasive, Incorporated2018115—
+6K180071STYLO Interbody Fusion DeviceLegend Spine Technologies20180—
+6K172941CASCADIA Interbody SystemK2m201852—
+6K172105The Plateau-LO Spacer SystemLife Spine, Inc.20181—
+6K173508Everest Spinal SystemK2m20189—
+6K173102Reliance Cervical IBF SystemReliance Medical Systems, LLC201715—
+6K171848FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO…Globus Medical, Inc.201755—
+6K173182ProLift® Expandable SystemLife Spine, Inc.201737—