510(k) Report

Devices descending from K001340

2,423 later devices reach Stackable Cage System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K180373CancelleX Porous Titanium Lumbar Interbody DeviceXenco Medical, LLC20180—
+5K180777K2M Expandable Interbody SystemK2m, Inc.20180—
+5K173947Lumbar Interbody Fusion System (OLLIF)Advanced Research Medical, LLC201801
+5K181079SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation201863—
+5K181115CxHA PEEK Cervical IBF SystemInnovasis, Inc.20188—
+5K180673Normandy VBR SystemZavation Medical Products, LLC20187—
+5K180364HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC2018106—
+5K180724SPIRA Open Matrix LLIFCamber Spine Technologies, LLC201810—
+5K180401TiWAVE-C™ Porous Titanium Cervical CageKalitec Direct, LLC20185—
+5K173189Lumfuse TPPrecifit Medical, Ltd.20180—
+5K173832InTice™-C Porous Ti Cervical Interbody SystemX-Spine Systems, Inc.201801
+5K180519HARRIER-SA™ Lumbar Interbody SystemChoicespine, LP20180—
+5K173892NuVasive® XLX Interbody SystemNu Vasive, Incorporated2018115—
+5K172166OLYMPIC Navigated InstrumentsAstura Medical20185—
+5K180002Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20182—
+5K173782UNiD Patient Specific 3D printed cageMedicrea International SA201823—
+5K172967Mercury® Spinal SystemSpinal Elements, Inc.20185—
+5K180056Genesys Spine AIS-C Cervical Anchored Interbody SystemGenesys Spine201818—
+5K173249CD HORIZON™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20181—
+5K172320Neurostructures Cavetto® Cervical Cage SystemNeurostructures, Inc.20183—
+5K172941CASCADIA Interbody SystemK2m201852—
+5K173025NuVasive® MLX® – Medial Lateral Expandable Lumbar Interbody System; NuVasive® AP…Nu Vasive, Incorporated20188—
+5K171312FortiCore®Nanovis, LLC20183—
+5K173702Juliet Ti LLSpineart20182—
+5K172330Blustone Synergy Silica SystemBlustone Synergy20170—
+5K172465Idys™ TLIF 3DTi CagesClariance, Sas20176—
+5K170389TAURUS PEEK Cage SystemMedyssey USA, Inc.20170—
+5K172349InFill® Interbody Fusion DevicePinnacle Spine Group, LLC20171—
+5K172009Cascadia Interbody SystemK2m, Inc.2017433
+5K172019Brisbane ALIF Device, Gladstone ALIF DeviceSignature Orthopaedics Pty, Ltd.20170—
+5K172083Idys™ ALIF SystemClariance, Sas20177—
+5K172341NuVasive® Modulus TLIF Interbody SystemNu Vasive, Incorporated2017163—
+5K173022SeaSpine Ventura NanoMetalene SystemSeaSpine Orthopedics Corporation20170—
+5K171914Cortina™ Lumbar Cage SystemNeurostructures, Inc.20172—
+5K172343Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D TechnologyRti Surgical, Inc.201710—
+5K172123NuVasive® Modulus XLIF Interbody SystemNu Vasive, Incorporated2017227—
+5K163366Shanghai Sanyou CARMEN Cervical Fusion SystemShanghai Sanyou Medical Co, Ltd.20170—
+5K172065Scarlet AC-TSpineart20172—
+5K171633NuVasive TLX Interbody SystemNu Vasive, Incorporated2017251—
+5K171107CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal SystemMedtronic Sofamor Danek USA, Inc.20178—
+5K172064Ti-Diagon Oblique TLIFCamber Spine Technologies201727—
+5K171893Blustone Synergy Lumbar Interbody Fusion System (Basalt, Magma, Obsidian), Blustone…Bluestone Synergy20172—
+5K171321K2M Navigation InstrumentsK2m201711
+5K171140Matrixx SystemNexxt Spine, LLC2017145—
+5K171657ShurFit 2C Lumbar Interbody Fusion SystemPrecision Spine, Inc.20174—
+5K170888Renovis S141 Lumbar Interbody Fusion SystemRenovis Surgical Technologies20175—
+5K171425Concorde LiftMedos International SARL201782
+5K163589SIGN IM NailSign Fracture Care International20170—
+5K170676HD Lumbar Interbody SystemHd Lifesciences, LLC2017122—
+5K170318NeoFuse Ti3D PLIF/TLIF/Cervical InterbodyHt Medical, LLC201749—
+5K170503EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular…Eit Emerging Implant Technologies GmbH20171992
+5K171046SeaSpine Cambria SystemSeaSpine Orthopedics Corporation201762—
+5K170844Gemini-C Hybrid Cervical Interbody SystemOsseus Fusion Systems, LLC20170—
+5K170830Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20175—
+5K170297Tranquil Interbody SystemNexus Spine, LLC201715—
+5K163494Summit Spine Channel Cervical Interbody Fusion SystemSummit Spine20171—
+5K171468FUSE Spinal SystemMedtronic Sofamor Danek20170—
+5K170961NuVasive CoRoent Small Interlock II SystemNu Vasive, Incorporated201718—
+5K162212Divergence-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc.201757—
+5K170679CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC®…Medtronic Sofamor Danek201786—
+5K171097MOJAVE Expandable Interbody SystemK2m, Inc.201717—
+5K163707NuVasive CoRoent Ti-C SystemNu Vasive, Incorporated201719—
+5K170953Tomcat Cervical Spinal SystemChoicespine, LP2017103—
+5K163581Navigated ELEVATE Inserter, Navigated Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.2017103—
+5K162206Zavation IBFZavation, LLC201724—
+5K170347CD HORIZON™ Fenestrated Screw SetMedtronic Sofamor Danek USA201791—
+5K163230NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2017276—
+5K170455MectaLIF Anterior Stand AloneMedacta International S.A.20174—
+5K162760Spine Wave Anterior Cervical Spine SystemSpine Wave, Inc.20171—
+5K160976Altus Spine Interbody Fusion SystemAltus Partners, LLC20178—
+5K162531Sterispine CCSafe Orthopaedics20160—
+5K163301CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.20162—
+5K162680SOVEREIGN® Spinal SystemMedtronic Sofamor Danek USA, Inc.201631—
+5K160222OIC Cervical PEEK SpacerThe Orthopaedic Implant Company20160—
+5K162066Reliance Spinal Screw SystemReliance Medical Systems, LLC20163—
+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—
+5K160663Lumbar Interbody Fusion System (ALIF, PLIF, LLIF, TPLIF)Evolution Spine, LLC20160—
+5K162379CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.201645—
+5K162715SeaSpine Spacer System- Hollywood NanoMetalene, Hollywood VI NanoMetalene, Ventura…SeaSpine Orthopedics Corporation2016103—
+5K162138NuVasive CoRoent Small Ti-C SystemNu Vasive, Incorporated2016135—
+5K161842Overwatch Spine SystemAmendia, Inc.201661
+5K162494CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.201627—
+5K161442NuVasive® CoRoent® Small Interlock™ SystemNu Vasive, Incorporated201694—
+5K161173Avenue® T TLIF CageLdr Spine USA, Inc.20163—
+5K162264Cascadia Interbody SystemK2m, Inc.2016169—
+5K161888JULIET® LL Lateral Lumbar CageSpineart2016145—
+5K161485Nanovis Intervertebral Body Fusion System and Forticore (R)Nanovis, LLC20165—
+5K160066Pro-Link® Stand-Alone Cervical Spacer SystemLife Spine, Inc.20163—
+5K161230NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated2016381—
+5K161627PASS LP Spinal SystemMedicrea International SA20167—
+5K152099Genesys Spine Apache® Anchored Cervical Interbody Fusion SystemGenesys Spine201619—
+5K153621Juliet® TiSpineart2016751
+5K153786Prow Fusion-VNlt Spine, Ltd.20166—
+5K152622Alta ACDF SystemBiomet Spine20160—
+5K160874Nanovis Intervertebral Body Fusion System and FortiCore®Nanovis, LLC20164—
+5K160916CoRoent® Ti-C SystemNu Vasive, Incorporated2016139—
+5K161280Cervical Stand Alone SystemOrthofix, Inc.201614—
+5K161363Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201675—