510(k) Report

Devices descending from K081917

1,008 later devices reach Depuy Spine Bengal, Concorde, Cougar, Devex and Leopard Systems through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+2K142744Mecta-C TiPEEKMedacta International201512—
+2K141665NuVasive CoRoent SystemNuvasive, Inc.2015588—
+2K143214SCARLET® AC-T Secured Anterior Cervical CageSpineart20153—
+2K141599Divergence Anterior Cervical Fusion SystemMedtronic Sofamor Danek USA, Inc.201516—
+2K142152Construx Mini Peek; Spacer System, TI Spacer System, Cervical Stand Alone SystemOrthofix, Inc.2015280—
+2K141333Arena-C Tifuse Cervical Intervertebral Body Fusion DeviceSpinefrontier, Inc.20140—
+2K140319Coroent TI-C SystemNuvasive, Inc.2014590—
+2K141314Scarlet AC-T Secured Anterior Cervical Cage and Associated InstrumentationSpineart201438—
+2K140417Divergence Mini-Plate Anterior Cervical Fusion SystemMedtronic Sofamor Danek, Inc.201411—
+2K132999Cervical Stand Alone SystemOrthofix, Inc.2014281—
+2K133614Aleutian Ibf SystemK2m, Inc.2014527—
+2K132483Innesis Peek Cervical CageBk Meditech, Co., Ltd.20140—
+2K133721Infill 41-Tlif Convex Oblique Device, Infill 43-Tlif Contour Oblique, Infill 44-Tlif…Pinnacle Spine Group, LLC20145—
+2K133967Interbody Cage SystemAurora Spine2014227—
+2K133192Mectalif TipeekMedacta International201416—
+2K132894Optio-C Anterior Cervical SystemZimmer Spine, Inc.201424—
+2K133126K7 Lumbar SpacersK7, LLC20131—
+2K132584Perimeter C Spinal SystemMedtronic Sofamor Danek USA, Inc.2013119—
+2K130699Aleutian Spinal SystemK2m, Inc.2013570—
+2K124034Mectalif AnteriorMedacta International201311—
+2K122037Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion System Peek Prevail…Medtronic Sofamor Danek, Inc.2013281—
+2K123388K7C SpacerK7, LLC20130—
+2K121649Construx Mini Peek TI Spacer SystemOrthofix2012289—
+2K121151Pro-Link Cervical Spacer SystemLife Spine, Inc.2012116—
+2K122896Cougar LS 15 Lateral Cage SystemMedos International SARL2012205—
+2K122366Tryptik CC Anterior Intersomatic Cervical CageSpineart20125—
+2K120819Stalif CCentinel Spine, Inc.2012206—
+2K113796Solitaire-C Cervical Spacer SystemEbi, LLC20121421
+2K112664Zavation Ibf SystemsZavation, LLC201137—
+2K103743Concorde Curve SystemJohnson & Johnson20110—
+3K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+3K253894BMD Titanium Spinal Fusion SystemGlobal Biomedica s.r.o.20260—
+3K254202MectaLIF 3D Metal AnteriorMedacta International S.A.20260—
+3K253559Ventana™ A Anterior Lumbar Interbody SystemSpinal Elements, Inc.20260—
+3K252610ZSFab Lumbar Interbody SystemZsfab, Inc.20251—
+3K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+3K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc.20251—
+3K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+3K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+3K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—
+3K250605EVOL® ha – Hyper C Cervical Interbody Fusion SystemCutting Edge Spine, LLC20250—
+3K242195Gemini Cervical Fusion Cage SystemZheJiang Decans Medical Devices Co., Ltd.20241—
+3K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc.20241—
+3K241164IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic)202412
+3K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+3K241396uCerv Flux™-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA, Inc.20240—
+3K240699SCARLET® AC-TiSpineart SA20240—
+3K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+3K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+3K232792icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec…Icotec AG20240—
+3K233375Tranquil-L Interbody SystemNexus Spine, LLC20240—
+3K233744Curiteva Porous PEEK Lumbar Interbody Fusion SystemCuriteva, Inc.20242—
+3K230639Align Cervical Interbody Fusion SystemAcuity Surgical Devices, LLC20232—
+3K231763Stable-C Interbody SystemNexus Spine, LLC20236—
+3K232150ZSFab Cervical Interbody SystemZsfab, Inc.20234—
+3K222874CarboClear Cervical Cage System, CarboClear Cervical VBR SystemCarbofix Orthpedics, Ltd.20230—
+3K231241NanoHive Medical Lumbar Interbody SystemNanoHive Medical, LLC20230—
+3K231252Ventana™ L Spinal SystemSpinal Elements, Inc.20231—
+3K230329F3D Interbody SystemCorelink, LLC20230—
+3K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+3K230851Kodiak Lumbar Spacer SystemMet One Technologies, LLC20230—
+3K230708Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system); Anterior…Gbs Commonwealth Co., Ltd.20233—
+3K230583Tryptik TiSpineart SA20231—
+3K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+3K223043The Integrity Spine Core SystemIntegrity Spine20230—
+3K223362Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device4Web Medical, Inc.20233—
+3K221542Galileo Vertebral Body Replacement DeviceBright Spine20230—
+3K221266Cervical Spine Truss System (CSTS) Interbody Fusion Device4Web Medical, Inc.20233—
+3K223105Tesera-K SC SystemKyocera Medical Technologies, Inc.20225—
+3K221182Southern Transforaminal Lumbar Interbody Fusion (TLIF)Southern Medical (Pty), Ltd.20220—
+3K221545MectaLIF Anterior ExtensionMedacta International S.A.202226
+3K222203DualXSLIM (R) T/PLIFAmplify Surgical, Inc.20223—
+3K221172FOCUS Interbody SystemOc Medical Devices20220—
+3K220696uCerv Flux-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA20221—
+3K213791Unispace SA Cervical CageEdisoninno Co., Ltd.20222—
+3K221535Align Lumbar Interbody Fusion SystemAcuity Surgical Devices, LLC20223—
+3K220523restor3d TiDAL Lumbar Interbody Fusion DeviceRestor3D20222—
+3K212527Cervical Spine Truss System Plating Solution (CSTS-PS)4Web Medical, Inc.20220—
+3K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+3K213118Dakota ALIF SystemPrecision Spine, Inc.20220—
+3K220453FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20221—
+3K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20227—
+3K213980Peridot Spinal Interbody SystemGbs Commonwealth Co., Ltd.20224—
+3K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+3K212358Romero Cervical CageSpineup, Inc.20226—
+3K212075ShurFit Lumbar Interbody SystemPrecision Spine, Inc.20211—
+3K213115CHENA-C Spacer SystemKahtnu Surgical, Inc.20210—
+3K210573Velofix SA Cervical CageU&I Corporation20211—
+3K212853Cervical Stand-Alone SystemEminent Spine, LLC202118—
+3K211740DualXAmplify Surgical, Inc.20211—
+3K211474Kleiner KG2 SystemBAAT Medical Products B.V.20210—
+3K211769OneLIF Intervertebral Body Replacement SystemNovapproach Spine202112
+3K210470C-CURVE Interbody Fusion DeviceMedicrea International SA20210—
+3K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+3K210044Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System…Spinal Elements, Inc.20211—
+3K210214NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody SystemNu Vasive, Incorporated20213—
+3K203520Blustone Synergy Interbody Fusion SystemBlustone Synergy, LLC20210—
+3K203038Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20215—
+3K202380Born PT-LIF Cage HASpineworxx AG20210—
+3K202872Prase PEEK Anterior Cervical Interbody SpacerGbs Commonwealth Co., Ltd.20215—