510(k) Report

Devices descending from P000028

1,287 later devices reach Affinity (TM) Cage System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K191039Navigated T2 STRATOSPHERE Inserters and Navigated TemplatesMedtronic Sofamor Danek USA, Inc.201918—
+5K190885Elevation Spine Saber-C SystemElevation Spine201925—
+5K183249Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved…Stryker Spine20196—
+5K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+5K190680Favo S-TlifSilony Medical GmbH20190—
+5K182158UNiD Patient-matched PLIF cageMedicrea International SA201921—
+5K191408Nexxt Matrixx SystemNexxt Spine, LLC20190—
+5K182608Oyster ACIF CageSilony Medical GmbH20190—
+5K191263Idys ALIF TiVacClariance, Sas20190—
+5K190877Juliet® Ti LL Lumbar Interbody DeviceSpineart201911
+5K190147COLOSSEUM MeshGlobus Medical, Inc.20190—
+5K190092UNiD Patient specific 3D printed TLIF cageMedicrea International SA201913—
+5K190655SeaSpine® Shoreline™ ACS- Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation201974—
+5K183426MectaLIF Anterior Stand Alone ExtensionMedacta International S.A.20191—
+5K183397ChoiceSpine Stealth Cervical Spacer SystemChoicespine, LP201916—
+5K190193SpineEX Sagittae® Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20192—
+5K183705IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc.201999—
+5K183588Choice Spine Hawkeye Vertebral Body Replacement (VBR) SystemChoicespine20195—
+5K190067Velofix Interbody Fusion SystemU&I Corporation20193—
+5K181048Neo Cage System TMNeo Medical SA20191—
+5K182584Lucent® XPSpinal Elements, Inc.20183—
+5K181357PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc.201897—
+5K180665SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage SystemK2m, LLC20189—
+5K181837Spinal Elements Ti-Bond coated devicesSpinal Elements, Inc.201898—
+5K182322Duo Lumbar Interbody Fusion DeviceSpineology, Inc.20182—
+5K181644EIT Cellular Titanium® Lumbar Cage LLIFEit Emerging Implant Technologies GmbH2018141—
+5K181860NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2018159—
+5K181328T2 STRATOSPHERE™ Expandable Corpectomy SystemMedtronic Sofamor Danek USA, Inc.201828—
+5K173982FORTIFY Corpectomy SpacersGlobus Medical, Inc.20188—
+5K181655Renovis S180 Lateral Lumbar Interbody Fusion SystemRenovis Surgical Technologies20184—
+5K180777K2M Expandable Interbody SystemK2m, Inc.20180—
+5K180673Normandy VBR SystemZavation Medical Products, LLC20187—
+5K181261Curiteva Cervical Interbody Fusion SystemCuriteva, LLC20184—
+5K181203Juliet TiSpineart20181—
+5K180724SPIRA Open Matrix LLIFCamber Spine Technologies, LLC201810—
+5K180502S128 Anterior Lumbar Interbody Fusion (ALIF) SystemRenovis Surgical Technologies, Inc.201811—
+5K173782UNiD Patient Specific 3D printed cageMedicrea International SA201823—
+5K172105The Plateau-LO Spacer SystemLife Spine, Inc.20181—
+5K173702Juliet Ti LLSpineart20182—
+5K173182ProLift® Expandable SystemLife Spine, Inc.201737—
+5K172349InFill® Interbody Fusion DevicePinnacle Spine Group, LLC20171—
+5K172009Cascadia Interbody SystemK2m, Inc.2017433
+5K170389TAURUS PEEK Cage SystemMedyssey USA, Inc.20170—
+5K172437CONSTRUX® Mini PTC Spacer System, FORZA® PTC Spacer System, PILLAR® SA PTC Spacer SystemOrthofix, Inc.2017143
+5K173175Paramount Anterior Cervical Cage SystemSpine Wave, Inc.20170—
+5K172341NuVasive® Modulus TLIF Interbody SystemNu Vasive, Incorporated2017163—
+5K172123NuVasive® Modulus XLIF Interbody SystemNu Vasive, Incorporated2017227—
+5K171633NuVasive TLX Interbody SystemNu Vasive, Incorporated2017251—
+5K170157INDEPENDENCE® SpacersGlobus Medical, Inc.2017109—
+5K172064Ti-Diagon Oblique TLIFCamber Spine Technologies201727—
+5K171704CAPRI Corpectomy Cage SystemK2m201710—
+5K170676HD Lumbar Interbody SystemHd Lifesciences, LLC2017122—
+5K170395Talos® Lumbar (HA) PEEK IBF DevicesMeditech Spine, LLC201710—
+5K171097MOJAVE Expandable Interbody SystemK2m, Inc.201717—
+5K163707NuVasive CoRoent Ti-C SystemNu Vasive, Incorporated201719—
+5K163491NuVasive CoRoent Small Interbody SystemNu Vasive, Incorporated2017289—
+5K170455MectaLIF Anterior Stand AloneMedacta International S.A.20174—
+5K162918Atlas Spine Expandable Interbody SystemAtlas Spine, Inc.201729—
+5K162587Roccia® AcifSilony Medical GmbH20171—
+5K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation201679—
+5K162103Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine…Choicespine, LP2016161—
+5K162431Luna 3D Interbody Fusion SystemBenvenue Medical, Inc.20163—
+5K160924Amendia Interbody Fusion DevicesAmendia, Inc.2016166—
+5K162138NuVasive CoRoent Small Ti-C SystemNu Vasive, Incorporated2016135—
+5K161173Avenue® T TLIF CageLdr Spine USA, Inc.20163—
+5K161230NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated2016381—
+5K161223TransContinental® M Spacers and InterContinental® Plate-SpacersGlobus Medical, Inc.2016117—
+5K160906Rampart O Lumbar Interbody Fusion Device, Rampart T Lumbar Interbody Fusion Device…Spineology, Inc.201627—
+5K153786Prow Fusion-VNlt Spine, Ltd.20166—
+5K160916CoRoent® Ti-C SystemNu Vasive, Incorporated2016139—
+5K153720ENZA Zero-Profile Anterior Interbody FusionCamber Spine Technologies20164—
+5K153627NuVasive® TLX Interbody SystemNu Vasive, Incorporated2016252—
+5K160291Optimus ALIF SystemAmendia, Inc.20160—
+5K151726AVS AL and AVS ALign PEEK Spacers, AVS PL and AVS UniLIF PEEK Spacers, AVS TL PEEK…Stryker Corporation20161391
+5K151312VerteLP Interbody Fusion DeviceVgi, LLC201601
+5K151310Amendia Interbody Fusion DevicesAmendia, Inc.2016169—
+5K152304Tritanium PL CageStryker20154481
+5K151472NuVasive CoRoent Lumbar SystemNu Vasive, Incorporated2015479—
+5K151322Amendia Interbody Fusion DevicesAmendia, Inc.20152261
+5K151184InFill Interbody Fusion DevicesPinnacle Spine Group, LLC20153—
+5K150994NuVasive CoRoent Thoracolumbar ImplantsNu Vasive, Incorporated2015402—
+5K150521Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) SystemRti Surgical, Inc. Dba Rti Biologics201512—
+5K143595NuVasive (R) CCX-L Interbody SystemNu Vasive, Incorporated2015253—
+5K143258PLIF STS, TLIF STS, OLIF STS (Spinal Truss System)4Web, Inc.2015211—
+5K150206InFill Interbody Fusion DevicesPinnacle Spine Group, LLC20152—
+5K143616AccuLIF TL and PL CageStryker Corporation20154694
+5K143228Ancora LLC Interbody Fusion DeviceFrontier Medical Devices, Inc.20150—
+5K143126Renovis S141 Lumbar Interbody Cage SystemRenovis Surgical Technologies2015237—
+5K140142Choice Spine Lumbar Spacer System (Sabre, Shark, Hornet, Harpoon)Choicespine, LP2014172—
+5K140106S128 Anterior Lumbar Interbody Fusion (Alif) SystemRenovis Surgical Technologies, Inc.2014265—
+5K121693A-Wedge Anterior Interbody System (a-Wedge Ais)Sapphire Medical Group, Inc.201221—
+5K121211VU Apod Intervertebral Body Fusion DeviceTheken Spine, LLC2012129—
+6K262025Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis…INNO Holdings Inc. DBA Innovasis20260—
+6K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc.20260—
+6K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—
+6K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+6K253151Fule Interbody Fusion Cage SystemBeijing Fule Science & Technology Development Co., Ltd.20260—
+6K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, Inc.20260—
+6K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+6K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—