510(k) Report

Devices descending from K040928

1,504 later devices reach Expandable Peek VBR Implant through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K131178Idys Lif CagesClariance201311—
+4K131981Cezanne II Interbody Fusion SystemAccel Spine201354
+4K130641Logic Stand-Alone Intervertebral Body Fusion DeviceBinder Biomedical, Inc.20130—
+4K130948C-Fuse Cervical Intervertebral Body Fusion SystemSouthern Spine, LLC201313—
+4K130699Aleutian Spinal SystemK2m, Inc.2013570—
+4K130434Octane Straight, Octane Straight - Lordotic, Octane Straight I/R, Octane Straight I/R -…Exactech, Inc.201311—
+4K123767Lanx Fusion System- SALanx, Inc.20133244
+4K123388K7C SpacerK7, LLC20130—
+4K123207Primalif TM Llif Unitary Peek Lateral Lumbar Interbody Fusion SystemOsteomed LP201216—
+4K120031Chesapeake Spinal SystemK2m, Inc.2012334—
+4K113138Aleutian SystemK2m, Inc.2012549—
+4K112664Zavation Ibf SystemsZavation, LLC201137—
+4K103169AleuttianK2m, Inc.2011572—
+4K102322Stingray Cervical Cage; Shark Implant (Plif); Bull Shark Implant (Plif); Tiger Implant…Omni Surgical, L.P.20116—
+4K100037Advanced Vertebral Solutions Express BFDAdvanced Vertebral Solutions, LLC20100—
+4K100820Wenzel Spine Varilift Interbody Fusion SystemWenzel Spine201016—
+4K101302Aleutian Ibf SystemK2m, Inc.2010595—
+4K073177Pioneer Intervertebral Fusion Device SystemPioneer Surgical Technology20087751
+4K080401Shell Cage, Wave Cage, Loop CageAdvanced Medical Technologies AG2008840—
+4K073291Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.20081,103—
+4K080083Intrepid Spinal SystemMedtronic Sofamor Danek20089328
+4K073502Vertebron VBR SystemVertebron, Inc.200812—
+5K261049Scala® TLSpineart SA20260—
+5K261408SABER-XA SystemElevation Spine20260—
+5K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+5K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+5K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+5K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+5K254202MectaLIF 3D Metal AnteriorMedacta International S.A.20260—
+5K253559Ventana™ A Anterior Lumbar Interbody SystemSpinal Elements, Inc.20260—
+5K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+5K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+5K253577IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)Medicrea International S.A.S. (Medtronic)20250—
+5K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc.20250—
+5K252610ZSFab Lumbar Interbody SystemZsfab, Inc.20251—
+5K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+5K251117Cervical Spine Truss System (CSTS)4Web Medical20250—
+5K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—
+5K243915FIX-C 3D Ti ACIF SystemJeil Medical Corporation20250—
+5K243670Idys® LIFClariance20240—
+5K242195Gemini Cervical Fusion Cage SystemZheJiang Decans Medical Devices Co., Ltd.20241—
+5K241992Catalyft™ LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.20240—
+5K242267Gemini Medical Cage SystemZheJiang Decans Medical Devices Co., Ltd.20241—
+5K241605Adaptix™ PEEK Interbody System with Nanotechnology; Capstone Control™ PEEK Spinal System…Nanovis, LLC20240—
+5K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+5K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical20244—
+5K240838Spectrum Spine Cervical Cage SystemSpectrum Spine, Inc.20244—
+5K241396uCerv Flux™-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA, Inc.20240—
+5K240699SCARLET® AC-TiSpineart SA20240—
+5K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AG20240—
+5K231715MONDRIAN™ Anterior Lumbar Plate SystemCtl Medical Corporation20240—
+5K232348RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion SystemMiRus, LLC20231—
+5K230478Acro Composites Interbody SystemAcro Composites, LLC20230—
+5K232123MectaLIF Anterior Lag ExtensionMedacta International S.A.20231—
+5K232481RIGEL™ 3DR Anterior Cervical Corpectomy SystemMiRus, LLC20230—
+5K231486Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20231—
+5K231076VariLift®-C Interbody Fusion SystemWenzel Spine, Inc.20234—
+5K232530Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemNexus Spine, LLC20235—
+5K232154MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate FixationMiRus, LLC20230—
+5K222988neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D CervicalHt Medical D.B.A. Xenix Medical20232—
+5K232150ZSFab Cervical Interbody SystemZsfab, Inc.20234—
+5K230608SPICCA Stand-Alone Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+5K231252Ventana™ L Spinal SystemSpinal Elements, Inc.20231—
+5K230329F3D Interbody SystemCorelink, LLC20230—
+5K230026SqualeImplanet, S.A.20230—
+5K223688CONDUIT™ Lateral Lumbar Intervertebral Fusion Cage, CONDUIT™ InstrumentsMedos International Sàrl20230—
+5K223776PEEK Spinal Infusion CageChangzhou Geasure Medical Apparatus and Instruments Co., Ltd.20230—
+5K223231Ti-Largo Cervical Interbody SystemFlospine20230—
+5K223362Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device4Web Medical, Inc.20233—
+5K223105Tesera-K SC SystemKyocera Medical Technologies, Inc.20225—
+5K2136534CIS Black Marlin Plif Cage System, 4CIS Dolphin Tlif Cage SystemSolco Biomedical Company India Private Limited20220—
+5K223153Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.20220—
+5K223190Hive™ Standalone Cervical SystemNanoHive Medical, LLC20225—
+5K221182Southern Transforaminal Lumbar Interbody Fusion (TLIF)Southern Medical (Pty), Ltd.20220—
+5K222903Tailored-H Cervical Stand Alone SystemBespoke Technologies, LLC20220—
+5K221162UniVy OsteoVy Cervical IBF SystemVy Spine, LLC20222—
+5K221172FOCUS Interbody SystemOc Medical Devices20220—
+5K220696uCerv Flux-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA20221—
+5K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+5K213791Unispace SA Cervical CageEdisoninno Co., Ltd.20222—
+5K220523restor3d TiDAL Lumbar Interbody Fusion DeviceRestor3D20222—
+5K212450Keos Anterior Cervical Interbody Fusion Device SystemKeos20220—
+5K212527Cervical Spine Truss System Plating Solution (CSTS-PS)4Web Medical, Inc.20220—
+5K220115ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion SystemMiRus, LLC20220—
+5K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+5K214010Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA202249—
+5K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC20223—
+5K213118Dakota ALIF SystemPrecision Spine, Inc.20220—
+5K213355Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20224—
+5K220453FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20221—
+5K212980Tesera-k ALIF SystemKyocera Medical Technologies, Inc.20222—
+5K212715Vy Spine ClariVy Cervical IBF SystemVy Spine, LLC20216—
+5K212524Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.202155—
+5K213115CHENA-C Spacer SystemKahtnu Surgical, Inc.20210—
+5K212653Catalyft LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.202127
+5K210573Velofix SA Cervical CageU&I Corporation20211—
+5K211845Deploy Expandable Interbody SystemSouthern Spine, LLC20210—
+5K212831MectaLIF ExtensionMedacta International S.A.20211—
+5K212389Advantage Lumbar System - ALIF, PLIF, DLIF, TLIFIntelivation, LLC20210—
+5K211474Kleiner KG2 SystemBAAT Medical Products B.V.20210—