510(k) Report

Devices descending from K081614

843 later devices reach Zeus Small Cervical Cage and Large, Extra Large, Curved and Straight Lumbar… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K213030Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc.20233—
+3K223146EVOLUTION SPINE Interbody SystemEvolution Spine20239—
+3K221172FOCUS Interbody SystemOc Medical Devices20220—
+3K220523restor3d TiDAL Lumbar Interbody Fusion DeviceRestor3D20222—
+3K211837Altus Spine Interbody Standalone Fusion SystemAltus Partners, LLC20220—
+3K213359SeaSpine WaveForm, C Interbody SystemSeaSpine Orthopedics Corporation20217—
+3K212389Advantage Lumbar System - ALIF, PLIF, DLIF, TLIFIntelivation, LLC20210—
+3K211769OneLIF Intervertebral Body Replacement SystemNovapproach Spine202112
+3K210382Blustone Synergy Diamond SA Cervical SystemBlustone Synergy, LLC20210—
+3K210497SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202139—
+3K203520Blustone Synergy Interbody Fusion SystemBlustone Synergy, LLC20210—
+3K200458Tailored-C Cervical Interbody Fusion SystemBespoke Technologies20203—
+3K201643ChoiceSpine Tiger Shark Cervical Spacer SystemChoice Spine, LLC20204—
+3K201193SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202018—
+3K202065DOLOMITE Anterior Cervical Stabilization SystemAstura Medical, LLC20203—
+3K201939GAIA Lumbar Interbody Fusion Device (LIFD) FamilyPrinterprezz20200—
+3K202190Oculus-SA Lumbar Cage SystemNeurostructures20200—
+3K201073Seaspine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202017—
+3K201646Shoreline ACS (Anterior Cervical System)SeaSpine Orthopedics Corporation202020—
+3K201769Cavetto [MAX] Cervical Cage SystemNeurostructures, Inc.20200—
+3K192863MONDRIAN Lumbar Interbody Fusion Cage SystemCtl Medical Corporation20203—
+3K191906MiRus 3D Printed Lumbar Interbody Fusion Systems consisting of the Callisto 3D Printed…MiRus, LLC20206—
+3K200541Hive™ Stand-alone Anterior Lumbar Interbody SystemHd Lifesciences, LLC20201—
+3K192492EL CAPITAN Anterior Lumber Interbody SystemAstura Medical, LLC202010—
+3K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine20207—
+3K1920444CIS Marlin PEEK ACIF CageSolco Biomedical Co., Ltd.20190—
+3K182987Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20199—
+3K1803473d CageFims Co., Ltd.20190—
+3K190426ALTA Anterior Cervical Corpectomy SystemAstura Medical, LLC20193—
+3K192054Endoskeleton TAS PlateTitan Spine, Inc.20190—
+3K192018Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic…Titan Spine, Inc.20191024
+3K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer…Choice Spine, LLC20194—
+3K191565Endoskeleton TCS Interbody Fusion DeviceTitan Spine, Inc.201901
+3K183064TxTi IBF SystemInnovasis, Inc.2019481
+3K190618RIGEL PEEK Anterior Cervical Interbody Fusion SystemMiRus, LLC20191—
+3K183184FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.201912—
+3K183557Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device…Titan Spine, Inc.20191043
+3K180822VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion SystemWenzel Spine, Inc.20195—
+3K181829Velofix TLIF CageU&I Corporation20181—
+3K181590Neurostructures Cavetto® [MAX] Cervical Cage SystemNeurostructures, Inc.20180—
+3K181295Genesys Spine AIS-C Cervical Stand-Alone SystemGenesys Spine201817—
+3K180674EVOL® ha-C Cervical Interbody Fusion SystemCutting Edge Spine, LLC20183—
+3K180675Atlas Spine Expandable Cervical Interbody SystemAtlas Spine, Inc.20182—
+3K173832InTice™-C Porous Ti Cervical Interbody SystemX-Spine Systems, Inc.201801
+3K180642Pro-Link® Ti Stand-Alone Cervical Spacer SystemLife Spine, Inc.20182—
+3K172484A-CIFT SoloFuseSpinefrontier, Inc.201871
+3K180056Genesys Spine AIS-C Cervical Anchored Interbody SystemGenesys Spine201818—
+3K173128Alamo® CAlliance Partners, LLC20182—
+3K173324ALTA Anterior Cervical Interbody SpacerAstura Medical201827—
+3K173535Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TAS Hyperlordotic Interbody…Titan Spine, LLC20181052
+3K173159Cervical Spinal Truss System (CSTS) Interbody Fusion Device4Web, Inc.201812—
+3K172419Velofix™ TLIF CageU&I Corporation20172—
+3K172253Altus Spine Cervical Interbody Fusion SystemAltus Partners, LLC20170—
+3K172446SPIRA-C Open Matrix Cervical InterbodyCamber Spine Technologies20176—
+3K172392Lateral Spinal Truss System (LSTS) Interbody Fusion Device4Web, Inc.20171—
+3K172587Mecta-C with titanium markers and Mecta-C TiPEEK with titanium markersMedacta International S.A.20170—
+3K171351Posterior Spine Truss System (PSTS) Interbody Fusion Device4Web, Inc.20177—
+3K171496Tritanium C Anterior Cervical CageStryker Spine2017129—
+3K170851Anterior Spine Truss System (STS) Interbody Fusion Device4Web, Inc.20175—
+3K171656Genesys Spine Apache Interbody Fusion SystemGenesys Spine20170—
+3K170399Endoskeleton TO Interbody Fusion Device (IBD)Titan Spine, LLC2017105—
+3K163481HALF DOME Posterior Lumbar Interbody SystemAstura Medical201731—
+3K163269Endoskeleton (R) TAS Interbody Fusion Device / Endoskeleton (R) TAS Hyperlordotic…Titan Spine, LLC2017143—
+3K170243LOSPA IS TLIF & DLIF CagesCorentec Co., Ltd.20170—
+3K161809ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc.20165—
+3K161438Genesys Spine Apache® Anterior Lumbar Interbody Fusion SystemGenesys Spine201611—
+3K161404Genesys Spine Apache® Lateral Lumbar Interbody Fusion SystemGenesys Spine201610—
+3K153615NeoFuse HA Enhanced PLIF/TLIFHt Medical, LLC201650—
+3K153123Genesys Spine Apache Interbody Fusion SystemGenesys Spine201612—
+3K152475FORZA PTC Spacer SystemOrthofix, Inc.2016236—
+3K152515TOMCAT Cervical Spinal SystemChoicespine, LP2015108—
+3K153122Endoskeleton (r) TCS SystemTitan Spine, LLC20151061
+3K151596Endoskeleton TCS Interbody Fusion DeviceTitan Spine, LLC20151101
+3K142269Reliance Cervical IBF SystemReliance Medical Systems, LLC201523—
+3K150130Ascendant TM Cervical Spacer SystemExactech, Inc.20157—
+3K142744Mecta-C TiPEEKMedacta International201512—
+3K141798Sypher Spacer SystemBiogennix, LLC20151—
+3K142152Construx Mini Peek; Spacer System, TI Spacer System, Cervical Stand Alone SystemOrthofix, Inc.2015280—
+3K142328nvcNvision Biomedical Technologies, LLC20144—
+3K142594nva, nvp, nvtNvision Biomedical Technologies, LLC20144—
+3K1421124WEB Spinal Implant Products4Web, Inc.201433—
+3K141405Mobis II ST Spinal ImplantSignus Medizintechnik GmbH2014461—
+3K133340Spineworks Anterior Lumbar DeviceSpineworks, LLC201413—
+3K140003Coroent Small Interbody SystemNuvasive, Inc.2014453—
+3K132483Innesis Peek Cervical CageBk Meditech, Co., Ltd.20140—
+3K130913Genesys Spine Apache Lateral Lumbar Interbody Fusion SystemGenesys Spine201314—
+3K122872Intervertebral Body Fusion DeviceDio Medical Co., Ltd.201316—
+3K120401Alamo TAlliance Partners, LLC20121—
+3K120966Depuy Pulse Lumbar Cage SystemMedos International SARL201225—
+3K120024Mectalif TransforaminalMedacta International S.A.201223—
+4K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+4K260840BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20261—
+4K250773Luna® Ti Interbody Fusion SystemSpinal Elements, Inc.20260—
+4K254061Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc.20260—
+4K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+4K250076Endeavor™ Stand-Alone Cervical IBF SystemInnovasis20250—
+4K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting20250—
+4K251459OneLIF™ Interbody Fusion SystemNovapproach Spine, LLC20250—
+4K250605EVOL® ha – Hyper C Cervical Interbody Fusion SystemCutting Edge Spine, LLC20250—
+4K243188Cylox® STSignus Medizintechnik GmbH20250—