510(k) Report

Devices descending from P950019

1,482 later devices reach Ray Threaded Fusion Cage (TFC)(TM) with Instrumentation through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K170399Endoskeleton TO Interbody Fusion Device (IBD)Titan Spine, LLC2017105—
+1K152501Spinal Jaxx Interbody Fusion DeviceNeuropro Spinaljaxx, Inc.201601
+1K152512Half Dome Posterior Lumbar Interbody SystemAstura Medical201633—
+1K143572Intersomatic Cervical Device - DICOM PEEK, Intersomatic Intervertebral Space Maintenance…Osteomed Implantes, Ltda20150—
+1K143126Renovis S141 Lumbar Interbody Cage SystemRenovis Surgical Technologies2015237—
+1K141980Leva (TM) Spacer SystemSpine Wave, Inc.20159—
+1K132907Plif Lite and Tlif LiteSintea Plustek20140—
+1K123758Tasmin RSignus Medizintechnik GmbH20141—
+1K131296Varilift-L Interbody Fusion DeviceWenzel Spine, Inc.20130—
+1K123100Intess Lumbar CageKalitec Direct, LLC20135—
+1K120966Depuy Pulse Lumbar Cage SystemMedos International SARL201225—
+1K111820Synster Cervical Cage, Alif Cage, Plif Cage, Ptlif Cage, Tlif CageBm Korea Co., Ltd.201220—
+1K112648Asfora Bullet CageMedical Designs, LLC201214—
+1K113540Reliance Lumbar Ibf SystemReliance Medical Systems, LLC201212—
+1K111792Mobis, Moval, Semial, Tetrismodel Peek and Titanium, Kimba Model Standard and MiniSignus Medizintechnik GmbH2012470—
+1K110562Telamon Peek Spinal SystemMedtronic Sofamor Danek USA2011306—
+1K110177Helena SystemRoyal Oak Medical Devices20110—
+1K103814Pezo Interbody Cages SystemUlrich GmbH & Co. KG20114—
+1K103034Genesys Spine Interbody Fusion SystemGenesys Spine20101371
+1K102067Endoskeleton toTitan Spine, LLC2010337—
+1K100042Difusion Technologies Xiphos Interbody Fusion SystemDifusion Technologies2010864—
+1K100820Wenzel Spine Varilift Interbody Fusion SystemWenzel Spine201016—
+1K092901Epicage Interbody Fusion DeviceR Tree Innovations2010609—
+1K094025Crescent Spinal SystemMedtronic Sofamor Danek2010838—
+1K092017Pivotec Lumbar Interbody Fusion Device (Lifd)Captiva Spine, Inc.200924—
+1K090353Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek2009796—
+1K091122Diana Fusion CageSignus Medical20090—
+1K090048Asfora Bullet Cage SystemMedical Designs, LLC200931—
+1K083714Endoskeleton TT Interbody Fusion Device (Ibd)Titan Spine, LLC2009412—
+1K090064Eminent Spine Interbody Fusion SystemEminent Spine20097011
+1K090376Spinesmith Cynch Spinal SystemSpine Smith Partners L.P.2009476—
+1K081673Dyn-Alif Anterolateral Intervertebral Body Fusion DeviceIonics Medical Corp.20080—
+1K081177Blackstone Medical, Inc., Pillar Spacer SystemBlackstone Medical, Inc.2008848—
+1K080615Endoskeleton TA Interbody Fusion Device (Ibd)Titan Spine, LLC2008564—
+1K073291Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.20081,103—
+1K080058Turbo Prime Ibd SystemSpineselect, LLC20081—
+1K080083Intrepid Spinal SystemMedtronic Sofamor Danek20089328
+1K073470Avs PL Peek Spacers, Models 48351XXX and 48353XXXStryker Spine20081,102—
+2K241992Catalyft™ LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.20240—
+2K242267Gemini Medical Cage SystemZheJiang Decans Medical Devices Co., Ltd.20241—
+2K241438Signus Tetris™ St; Signus Tetris™ R StSignus Medizintechnik GmbH20240—
+2K230219Eminent Spine 3D Lumbar Interbody Fusion SystemsEminent Spine, LLC20234—
+2K223335SIRION Lateral Lumbar Interbody SystemAstura Medical20230—
+2K223776PEEK Spinal Infusion CageChangzhou Geasure Medical Apparatus and Instruments Co., Ltd.20230—
+2K223146EVOLUTION SPINE Interbody SystemEvolution Spine20239—
+2K212701Eminent Spine 3D Cervical Interbody Fusion SystemEminent Spine20235—
+2K223153Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.20220—
+2K220902Navagio Lumbar CageKalitec Medical, LLC20220—
+2K214010Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA202249—
+2K214047EL CAPITAN Anterior Lumbar Interbody Fusion SystemAstura Medical20223—
+2K212524Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.202155—
+2K212070KMTI S141 Lumbar Interbody Fusion SystemKyocera Medical Technologies, Inc.20210—
+2K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+2K210425Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.2021561
+2K202495SIRION Lateral Lumbar Interbody FusionAstura Medical, LLC20216—
+2K201287Impulse Interbody Fusion SystemDegen Medical20208—
+2K201145X-Pac Expandable Lumbar Cage SystemExpanding Innovations, Inc.20204—
+2K201267Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek202079—
+2K192492EL CAPITAN Anterior Lumber Interbody SystemAstura Medical, LLC202010—
+2K192006SIRION Lateral Lumbar Interbody SystemAstura Medical, LLC202014—
+2K191788CAPSTONE Spinal System, CLYDESDALE PTC Spinal System, CRESCENT Spinal System, CRESCENT…Medtronic Sofamor Danek USA, Inc.20200—
+2K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+2K191581Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion…Titan Spine, Inc.202081—
+2K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine20207—
+2K191796Neo Cage SystemNeo Medical SA20190—
+2K182987Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20199—
+2K190544XIHPOS™ ZFUZE™ Interbody Fusion SystemDifusion Technologies20190—
+2K1803473d CageFims Co., Ltd.20190—
+2K191537eCarbon IBDsBack 2 Basics Direct, LLC20193—
+2K190398Republic Spine Restore Intervertebral Body Fusion SystemRepublic Spine, LLC20190—
+2K192018Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic…Titan Spine, Inc.20191024
+2K190889Republic Spine Restore Cervical Interbody Fusion SystemRepublic Spine, LLC20190—
+2K190165Capstone Control™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20196—
+2K182877HALF DOME Posterior Lumbar Interbody SystemAstura Medical, LLC201921—
+2K183049Reliance Lumbar IBF SystemReliance Medical Systems, LLC20197—
+2K183557Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device…Titan Spine, Inc.20191043
+2K181048Neo Cage System TMNeo Medical SA20191—
+2K180228II-Type Intervertebral SpacerPaonan Biotech Co., Ltd.20191—
+2K181118Reliance Lumbar IBF SystemReliance Medical Systems20190—
+2K182210TiWAVE-L Porous Titanium Lumbar CageKalitec Medical, LLC20193—
+2K181625Life Spine Resolute™ Threaded Cage SystemLife Spine, Inc.20180—
+2K181397DualXInnovasive, Inc.201815—
+2K181591Fixated Asfora BULLET CAGE® (FABC)Medical Designs, LLC20180—
+2K181702Tranquil-L Interbody SystemNexus Spine, LLC20188—
+2K181295Genesys Spine AIS-C Cervical Stand-Alone SystemGenesys Spine201817—
+2K173947Lumbar Interbody Fusion System (OLLIF)Advanced Research Medical, LLC201801
+2K173787X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage System…Medos International SARL20182—
+2K172480icotec Interbody Cage SystemIcotec AG20185—
+2K180687Reliance Lumber IBF SystemReliance Medical Systems20188—
+2K172947HALF DOME Posterior Lumbar Interbody SystemAstura Medical201822—
+2K173082Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20185—
+2K180056Genesys Spine AIS-C Cervical Anchored Interbody SystemGenesys Spine201818—
+2K172320Neurostructures Cavetto® Cervical Cage SystemNeurostructures, Inc.20183—
+2K172330Blustone Synergy Silica SystemBlustone Synergy20170—
+2K171689ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2017109—
+2K171107CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal SystemMedtronic Sofamor Danek USA, Inc.20178—
+2K172199ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT…Medtronic Sofamor Danek20176—
+2K163422Shanghai Sanyou PEEK Cage SystemShanghai Sanyou Medical Co, Ltd.20173—
+2K171893Blustone Synergy Lumbar Interbody Fusion System (Basalt, Magma, Obsidian), Blustone…Bluestone Synergy20172—
+2K171656Genesys Spine Apache Interbody Fusion SystemGenesys Spine20170—