510(k) Report

Devices descending from K073144

463 later devices reach Lanx Intervertebral Body Fusion Device through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K181531SpineEX Sagittae Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20183—
+1K150847Foundation Interbody DevicesCorelink, LLC201529—
+1K131122S128 Anterior Lumbar Interbody Fusion (Alif) SystemRenovis Surgical Technologies, LLC2013269—
+1K083815Lanx Fusion SystemLanx, Inc.2009451—
+1K073502Vertebron VBR SystemVertebron, Inc.200812—
+2K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+2K230808PEEK SA Anterior Lumbar Interbody Fusion (ALIF) SystemKyocera Medical Technologies, Inc.20230—
+2K223065Adcura® Sagittae® Lateral Lumbar Interbody Fusion DevicesAdcura, Inc.20220—
+2K200816SpineEX Sagittae Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20201—
+2K193320KMTI Tesera SA Anterior Lumbar Interbody Fusion (ALIF) SystemKyocera Medical Technologies, Inc.20203—
+2K190193SpineEX Sagittae® Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20192—
+2K182406Altus Spine Interbody Fusion SystemAltus Partners, LLC20191—
+2K183239CoreLink F3D™ Lateral SystemCorelink, LLC20188—
+2K181655Renovis S180 Lateral Lumbar Interbody Fusion SystemRenovis Surgical Technologies20184—
+2K180814CoreLink® M3™ Stand-Alone Anterior Lumbar SystemCorelink, LLC201818—
+2K180556Corelink Foundation 3D Anterior Lumbar SystemCorelink, LLC20185—
+2K181030Rubicon Lumbar Interbody Fusion SystemRubicon Spine, LLC20180—
+2K180502S128 Anterior Lumbar Interbody Fusion (ALIF) SystemRenovis Surgical Technologies, Inc.201811—
+2K173082Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20185—
+2K170553Altus Spine Interbody Fusion SystemAltus Partners, LLC20170—
+2K172253Altus Spine Cervical Interbody Fusion SystemAltus Partners, LLC20170—
+2K171329Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC20172—
+2K160976Altus Spine Interbody Fusion SystemAltus Partners, LLC20178—
+2K142634Biomet Spine Fusion SystemBiomet Spine, LLC20155—
+2K141443Infront Lumbar Interbody Fusion SystemInfront Medical, LLC20142—
+2K140106S128 Anterior Lumbar Interbody Fusion (Alif) SystemRenovis Surgical Technologies, Inc.2014265—
+2K103666Lanx LateralLanx, Inc.2011238—
+2K103660Lanx Cervical Intervertebral Body Fusion SystemLanx, Inc.201141—
+2K102738Lanx Fusion SystemLanx, LLC20113281
+2K092774Atlas Intervertebral Body CageSpinal Edge, LLC20100—
+3K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+3K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—
+3K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc.20241—
+3K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+3K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+3K230329F3D Interbody SystemCorelink, LLC20230—
+3K221545MectaLIF Anterior ExtensionMedacta International S.A.202226
+3K220523restor3d TiDAL Lumbar Interbody Fusion DeviceRestor3D20222—
+3K211837Altus Spine Interbody Standalone Fusion SystemAltus Partners, LLC20220—
+3K213118Dakota ALIF SystemPrecision Spine, Inc.20220—
+3K212980Tesera-k ALIF SystemKyocera Medical Technologies, Inc.20222—
+3K211769OneLIF Intervertebral Body Replacement SystemNovapproach Spine202112
+3K212070KMTI S141 Lumbar Interbody Fusion SystemKyocera Medical Technologies, Inc.20210—
+3K201939GAIA Lumbar Interbody Fusion Device (LIFD) FamilyPrinterprezz20200—
+3K202190Oculus-SA Lumbar Cage SystemNeurostructures20200—
+3K200541Hive™ Stand-alone Anterior Lumbar Interbody SystemHd Lifesciences, LLC20201—
+3K192492EL CAPITAN Anterior Lumber Interbody SystemAstura Medical, LLC202010—
+3K193645nva, nvp, and nvtNvision Biomedical Technologies, Inc.20203—
+3K182007Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies20180—
+3K182195Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20183—
+3K181591Fixated Asfora BULLET CAGE® (FABC)Medical Designs, LLC20180—
+3K180695FBC 921 (Alif)Fbc Device Aps20180—
+3K170235Lucent®Spinal Elements, Inc.2017107—
+3K170512Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC20176—
+3K151064Solitaire-C Cervical Spacer System, C-Thru Anterior Spinal System, Breckenridge Small…Biomet Spine201517—
+3K151483Biomet Spine Fusion SystemBiomet Spine, LLC20154—
+3K141135Juliet LLSpineart2014146—
+3K142095Renovis S134 Anterior Lumbar Interbody Fusion (Alif) SystemRenovis Surgical Technologies, Inc.2014254—
+3K132991C-Box Peek Cervical IbfInnovasis, Inc.20149—
+3K133557Juliet LL Lateral Lumbar CageSpineart2014147—
+3K131981Cezanne II Interbody Fusion SystemAccel Spine201354
+3K130948C-Fuse Cervical Intervertebral Body Fusion SystemSouthern Spine, LLC201313—
+3K123767Lanx Fusion System- SALanx, Inc.20133244
+3K123207Primalif TM Llif Unitary Peek Lateral Lumbar Interbody Fusion SystemOsteomed LP201216—
+4K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+4K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+4K254202MectaLIF 3D Metal AnteriorMedacta International S.A.20260—
+4K253559Ventana™ A Anterior Lumbar Interbody SystemSpinal Elements, Inc.20260—
+4K251459OneLIF™ Interbody Fusion SystemNovapproach Spine, LLC20250—
+4K242457EARP Interbody SystemRetropsoas Technologies, LLC20240—
+4K2402503D Printed PEEK Interbody SystemNvision Biomedical Technologies, Inc.20240—
+4K231715MONDRIAN™ Anterior Lumbar Plate SystemCtl Medical Corporation20240—
+4K234087restor3d TIDAL Lumbar Interbody Fusion SystemRestor3D20240—
+4K232123MectaLIF Anterior Lag ExtensionMedacta International S.A.20231—
+4K231252Ventana™ L Spinal SystemSpinal Elements, Inc.20231—
+4K223326Axiom PSR SystemRestor3D202301
+4K222554EL CAPITAN Anterior Lumbar Interbody FusionAstura Medical20235—
+4K212477EARP Interbody SystemNvision Biomedical Technologies, Inc.20221—
+4K214047EL CAPITAN Anterior Lumbar Interbody Fusion SystemAstura Medical20223—
+4K212389Advantage Lumbar System - ALIF, PLIF, DLIF, TLIFIntelivation, LLC20210—
+4K210044Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System…Spinal Elements, Inc.20211—
+4K202820Australis Anterior Lumbar Cage SystemPrism Surgical Designs Pty, Ltd.20200—
+4K192863MONDRIAN Lumbar Interbody Fusion Cage SystemCtl Medical Corporation20203—
+4K190055Duo Lumbar Interbody Fusion DeviceSpineology, Inc.20191—
+4K182584Lucent® XPSpinal Elements, Inc.20183—
+4K181829Velofix TLIF CageU&I Corporation20181—
+4K181837Spinal Elements Ti-Bond coated devicesSpinal Elements, Inc.201898—
+4K181818Scarlet AL-TSpineart201864—
+4K181115CxHA PEEK Cervical IBF SystemInnovasis, Inc.20188—
+4K180675Atlas Spine Expandable Cervical Interbody SystemAtlas Spine, Inc.20182—
+4K172941CASCADIA Interbody SystemK2m201852—
+4K173702Juliet Ti LLSpineart20182—
+4K171075Calix-C Cervical Interbody SpacerX-Spine Systems, Inc.201715—
+4K161888JULIET® LL Lateral Lumbar CageSpineart2016145—
+4K152622Alta ACDF SystemBiomet Spine20160—
+4K153695Biomet Spine Fusion SystemBiomet Spine, LLC201632
+4K143126Renovis S141 Lumbar Interbody Cage SystemRenovis Surgical Technologies2015237—
+4K133827A-Link ZOsteo Vasive, LLC2014262
+4K141791Biomet Fusion SystemBiomet Spine2014128—
+4K141129Exactech Cervical Spacer SystemExactech, Inc.20148—