510(k) Report

Devices descending from P000028

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K231763Stable-C Interbody SystemNexus Spine, LLC20236—
+3K230607SPICCA Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+3K222874CarboClear Cervical Cage System, CarboClear Cervical VBR SystemCarbofix Orthpedics, Ltd.20230—
+3K222004INTEGRATE -C Interbody Fusion SystemHappe Spine20236—
+3K220513NITRO Interbody Fusion Cage System FamilyCtl Medical Corporation20230—
+3K230026SqualeImplanet, S.A.20230—
+3K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+3K230583Tryptik TiSpineart SA20231—
+3K223043The Integrity Spine Core SystemIntegrity Spine20230—
+3K222041CYGNUS-C Standalone ACIF SystemGS Medical Co., Ltd.20231—
+3K220296Manta Ray TDF SpacerSeaSpine Orthopedics Corporation20231—
+3K223105Tesera-K SC SystemKyocera Medical Technologies, Inc.20225—
+3K222806Kodiak C Spinal Implant SystemMet One Technologies, LLC20221—
+3K221182Southern Transforaminal Lumbar Interbody Fusion (TLIF)Southern Medical (Pty), Ltd.20220—
+3K221844TDM Lumbar Interbody Fusion Cage SystemTdm Co., Ltd.20221—
+3K213791Unispace SA Cervical CageEdisoninno Co., Ltd.20222—
+3K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20227—
+3K220096Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20220—
+3K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+3K212266FIX-C PEEK Anterior Cervical Interbody SystemJeil Medical Corporation20217—
+3K210573Velofix SA Cervical CageU&I Corporation20211—
+3K212853Cervical Stand-Alone SystemEminent Spine, LLC202118—
+3K212389Advantage Lumbar System - ALIF, PLIF, DLIF, TLIFIntelivation, LLC20210—
+3K212562Idys-C ZP 3DTiClariance, SA20211—
+3K210470C-CURVE Interbody Fusion DeviceMedicrea International SA20210—
+3K212070KMTI S141 Lumbar Interbody Fusion SystemKyocera Medical Technologies, Inc.20210—
+3K211501Advantage-C PEEK Cervical lnterbody Fusion DeviceLntelivation, LLC20211—
+3K210521DEXA-C Cervical Interbody SystemAurora Spine, Inc.20210—
+3K210382Blustone Synergy Diamond SA Cervical SystemBlustone Synergy, LLC20210—
+3K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+3K203520Blustone Synergy Interbody Fusion SystemBlustone Synergy, LLC20210—
+3K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+3K203683CarboClear Lumbar Cage SystemCarbofix Orthpedics, Ltd.20211—
+3K200458Tailored-C Cervical Interbody Fusion SystemBespoke Technologies20203—
+3K201643ChoiceSpine Tiger Shark Cervical Spacer SystemChoice Spine, LLC20204—
+3K203076Mecta-C Stand Alone ExtensionMedacta International S.A.20200—
+3K193000Hexanium® ACIFSpinevision, S.A.S.202014—
+3K202305Zavation IBF SystemZavation Medical Products, LLC20209—
+3K200115Cavetto-SA Cervical Cage SystemNeurostructures, Inc.202019—
+3K201769Cavetto [MAX] Cervical Cage SystemNeurostructures, Inc.20200—
+3K192863MONDRIAN Lumbar Interbody Fusion Cage SystemCtl Medical Corporation20203—
+3K201585Monterey AL Interbody SystemStryker Corporation202044
+3K200592GS Medical AnyPlus PEEK Cage SystemGS Medical Co., Ltd.20206—
+3K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC202025—
+3K200543NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) SystemNexxt Spine, LLC202072—
+3K193645nva, nvp, and nvtNvision Biomedical Technologies, Inc.20203—
+3K191581Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion…Titan Spine, Inc.202081—
+3K193359SureMAX Family of Cervical SpacersAdditive Implants, Inc.202014—
+3K190426ALTA Anterior Cervical Corpectomy SystemAstura Medical, LLC20193—
+3K191584FORTICO Anterior Cervical Fixation SystemCamber Spine Technologies, LLC20192—
+3K192208CORNICE Cervical Spacer SystemLegend Spine Technologies20190—
+3K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer…Choice Spine, LLC20194—
+3K190870Cervical Spinal Truss System-Stand Alone (CSTS-SA)4Web, Inc.201910—
+3K191565Endoskeleton TCS Interbody Fusion DeviceTitan Spine, Inc.201901
+3K190618RIGEL PEEK Anterior Cervical Interbody Fusion SystemMiRus, LLC20191—
+3K190380nvcNvision Biomedical Technologies, Inc.20193—
+3K190322SCARLET® AC-T Secured Anterior Cervical CageSpineart20191—
+3K183083Shoreline Cervical Interbody RT SystemSeaSpine Orthopedics Corporation201960—
+3K182210TiWAVE-L Porous Titanium Lumbar CageKalitec Medical, LLC20193—
+3K183239CoreLink F3D™ Lateral SystemCorelink, LLC20188—
+3K180909REVEL SpacersGlobus Medical, Inc.201837—
+3K182007Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies20180—
+3K181140Axis Chena Cervical PEEK Spacer SystemAxis Orthopaedics20182—
+3K181590Neurostructures Cavetto® [MAX] Cervical Cage SystemNeurostructures, Inc.20180—
+3K181397DualXInnovasive, Inc.201815—
+3K181591Fixated Asfora BULLET CAGE® (FABC)Medical Designs, LLC20180—
+3K181702Tranquil-L Interbody SystemNexus Spine, LLC20188—
+3K181229TirboLOX-C Cervical IBFDCaptiva Spine, Inc.20180—
+3K181337Sypher Spacer SystemBiogennix, LLC20180—
+3K181483Tranquil Interbody SystemNexus Spine, LLC20186—
+3K180814CoreLink® M3™ Stand-Alone Anterior Lumbar SystemCorelink, LLC201818—
+3K180076Ti 3Z Interbody SystemZavation Medical Products, LLC20184—
+3K180556Corelink Foundation 3D Anterior Lumbar SystemCorelink, LLC20185—
+3K180695FBC 921 (Alif)Fbc Device Aps20180—
+3K181246Zavation IBF SystemZavation Medical Products, LLC201822—
+3K180364HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC2018106—
+3K172788MONET™ Anterior Cervical Interbody Fusion Cage SystemCtl Medical Corporation20181—
+3K180674EVOL® ha-C Cervical Interbody Fusion SystemCutting Edge Spine, LLC20183—
+3K173787X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage System…Medos International SARL20182—
+3K173722PATRIOT COLONIAL Spacer, SUSTAIN SpacerGlobus Medical, Inc.201894—
+3K172480icotec Interbody Cage SystemIcotec AG20185—
+3K180642Pro-Link® Ti Stand-Alone Cervical Spacer SystemLife Spine, Inc.20182—
+3K172484A-CIFT SoloFuseSpinefrontier, Inc.201871
+3K172568CervagePrecifit Medical, Ltd.20181—
+3K180002Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20182—
+3K173606SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu…SeaSpine Orthopedics Corporation201859—
+3K173082Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20185—
+3K173324ALTA Anterior Cervical Interbody SpacerAstura Medical201827—
+3K171312FortiCore®Nanovis, LLC20183—
+3K172212MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEK™Ctl Medical Corporation20181—
+3K173159Cervical Spinal Truss System (CSTS) Interbody Fusion Device4Web, Inc.201812—
+3K172926SeaSpine Vu cPOD, Zuma-C, Complete CervicalSeaSpine Orthopedics Corporation201761—
+3K172185Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20177—
+3K172419Velofix™ TLIF CageU&I Corporation20172—
+3K172019Brisbane ALIF Device, Gladstone ALIF DeviceSignature Orthopaedics Pty, Ltd.20170—
+3K172328SOVEREIGN™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201730—
+3K171689ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2017109—
+3K171107CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal SystemMedtronic Sofamor Danek USA, Inc.20178—
+3K163422Shanghai Sanyou PEEK Cage SystemShanghai Sanyou Medical Co, Ltd.20173—
+3K171496Tritanium C Anterior Cervical CageStryker Spine2017129—