510(k) Report

Devices descending from K003155

2,091 later devices reach Vertebral Body Replacement through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K200549Lucero Medical Cervical Cage SystemLucero Medical, LLC20200—
+6K203076Mecta-C Stand Alone ExtensionMedacta International S.A.20200—
+6K202065DOLOMITE Anterior Cervical Stabilization SystemAstura Medical, LLC20203—
+6K202771CD Horizon Spinal SystemMedtronic202021—
+6K202305Zavation IBF SystemZavation Medical Products, LLC20209—
+6K201453Fortilink Cages with TiPlus TechnologyParadigm Spine GmbH20204—
+6K200953NuVasive® Cohere® Thoracolumbar Interbody SystemNu Vasive, Incorporated2020141—
+6K201506Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical…Meditech Spine, LLC20200—
+6K201407CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.202054—
+6K201926CarboClear® Pedicle Screw System, CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202010—
+6K201251CarboClear Navigated InstrumentsCarboFix Orthopedics, Ltd.20209—
+6K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC202025—
+6K192492EL CAPITAN Anterior Lumber Interbody SystemAstura Medical, LLC202010—
+6K192145Galileo Vertebral Body Replacement DeviceBright Spine20201—
+6K200613Tritanium® X TL Expandable Curved Posterior Lumbar CageStryker Corporation20205—
+6K192006SIRION Lateral Lumbar Interbody SystemAstura Medical, LLC202014—
+6K193541NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2020157—
+6K193100RESPONSE™ Spine System, RESPONSE™ 4.5/5.0 Spine System, RESPONSE™ 5.5/6.0 Spine SystemOrthoPediatrics Corp.20204—
+6K192115SABLE Expandable SpacerGlobus Medical, Inc.202037—
+6K193011CD Horizon™ Fenestrated Screw SetMedtronic Sofamor Danek USA, Inc.202041—
+6K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine20207—
+6K190881Spinal Elements Navigated InstrumentsSpinal Elements, Inc.20194—
+6K191796Neo Cage SystemNeo Medical SA20190—
+6K182987Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20199—
+6K192026Peridot Intervertebral body fusion SystemGbs Commonwealth Co., Ltd.20196—
+6K191477AEON-C Stand Alone SystemHuvexel Co., Ltd.201910—
+6K190544XIHPOS™ ZFUZE™ Interbody Fusion SystemDifusion Technologies20190—
+6K190636NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201913—
+6K191822Nano FortiCore, FortiCoreNanovis, LLC20192—
+6K191212CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated…Medos International SARL20190—
+6K190483SPIRA Open Matrix ALIF and LLIFCamber Spine Technologies20199—
+6K191391HEDRON Lumbar SpacersGlobus Medical, Inc.201984—
+6K191243HEDRON Cervical SpacersGlobus Medical, Inc.201936—
+6K191576Mercury® Spinal System, Overwatch® Spinal SystemSpinal Elements, Inc.20195—
+6K190398Republic Spine Restore Intervertebral Body Fusion SystemRepublic Spine, LLC20190—
+6K191354Ti3Z Cervical Interbody SystemZavation Medical Products, LLC201913—
+6K191039Navigated T2 STRATOSPHERE Inserters and Navigated TemplatesMedtronic Sofamor Danek USA, Inc.201918—
+6K190885Elevation Spine Saber-C SystemElevation Spine201925—
+6K190680Favo S-TlifSilony Medical GmbH20190—
+6K190959ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2019108—
+6K182139AXTi Titanium Stand-Alone ALIF SystemInnovasis, Inc.201972—
+6K190360LineSider™ Spinal SystemIntegrity Implants, Inc.201913—
+6K190889Republic Spine Restore Cervical Interbody Fusion SystemRepublic Spine, LLC20190—
+6K183630SPINEART Navigation Instrument SystemSpineart SA20196—
+6K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC201993—
+6K183381Navigation Enabled InstrumentsStryker20191—
+6K182877HALF DOME Posterior Lumbar Interbody SystemAstura Medical, LLC201921—
+6K190655SeaSpine® Shoreline™ ACS- Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation201974—
+6K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+6K181048Neo Cage System TMNeo Medical SA20191—
+6K182477Cervical SpacerAdditive Implants, LLC201915—
+6K182284Tyber Medical PT Interbody SpacerTyber Medical, LLC20195—
+6K182982BridalVeil Navigated InstrumentsAstura Medical20190—
+6K183239CoreLink F3D™ Lateral SystemCorelink, LLC20188—
+6K180909REVEL SpacersGlobus Medical, Inc.201837—
+6K181899Roccia® PlifSilony Medical GmbH20180—
+6K181970MectaLIF Posterior ExtensionMedacta International S.A.20182—
+6K181860NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2018159—
+6K180215DYNA-LINK ELITE Stand-Alone Anterior Lumbar SystemLife Spine, Inc.20182—
+6K181295Genesys Spine AIS-C Cervical Stand-Alone SystemGenesys Spine201817—
+6K180814CoreLink® M3™ Stand-Alone Anterior Lumbar SystemCorelink, LLC201818—
+6K180556Corelink Foundation 3D Anterior Lumbar SystemCorelink, LLC20185—
+6K173947Lumbar Interbody Fusion System (OLLIF)Advanced Research Medical, LLC201801
+6K181030Rubicon Lumbar Interbody Fusion SystemRubicon Spine, LLC20180—
+6K180695FBC 921 (Alif)Fbc Device Aps20180—
+6K173832InTice™-C Porous Ti Cervical Interbody SystemX-Spine Systems, Inc.201801
+6K173892NuVasive® XLX Interbody SystemNu Vasive, Incorporated2018115—
+6K172166OLYMPIC Navigated InstrumentsAstura Medical20185—
+6K180002Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20182—
+6K172967Mercury® Spinal SystemSpinal Elements, Inc.20185—
+6K173082Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20185—
+6K180056Genesys Spine AIS-C Cervical Anchored Interbody SystemGenesys Spine201818—
+6K173249CD HORIZON™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20181—
+6K172320Neurostructures Cavetto® Cervical Cage SystemNeurostructures, Inc.20183—
+6K173025NuVasive® MLX® – Medial Lateral Expandable Lumbar Interbody System; NuVasive® AP…Nu Vasive, Incorporated20188—
+6K172105The Plateau-LO Spacer SystemLife Spine, Inc.20181—
+6K172185Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20177—
+6K172330Blustone Synergy Silica SystemBlustone Synergy20170—
+6K173182ProLift® Expandable SystemLife Spine, Inc.201737—
+6K170389TAURUS PEEK Cage SystemMedyssey USA, Inc.20170—
+6K172009Cascadia Interbody SystemK2m, Inc.2017433
+6K173148ACIFColigne AG20171—
+6K163595IMPIX 3D Print CagesMedicrea International SA2017282
+6K172328SOVEREIGN™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201730—
+6K172341NuVasive® Modulus TLIF Interbody SystemNu Vasive, Incorporated2017163—
+6K172123NuVasive® Modulus XLIF Interbody SystemNu Vasive, Incorporated2017227—
+6K163366Shanghai Sanyou CARMEN Cervical Fusion SystemShanghai Sanyou Medical Co, Ltd.20170—
+6K170119Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc.201711
+6K171633NuVasive TLX Interbody SystemNu Vasive, Incorporated2017251—
+6K171107CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal SystemMedtronic Sofamor Danek USA, Inc.20178—
+6K171893Blustone Synergy Lumbar Interbody Fusion System (Basalt, Magma, Obsidian), Blustone…Bluestone Synergy20172—
+6K171321K2M Navigation InstrumentsK2m201711
+6K171140Matrixx SystemNexxt Spine, LLC2017145—
+6K171656Genesys Spine Apache Interbody Fusion SystemGenesys Spine20170—
+6K170844Gemini-C Hybrid Cervical Interbody SystemOsseus Fusion Systems, LLC20170—
+6K170297Tranquil Interbody SystemNexus Spine, LLC201715—
+6K163494Summit Spine Channel Cervical Interbody Fusion SystemSummit Spine20171—
+6K171468FUSE Spinal SystemMedtronic Sofamor Danek20170—
+6K170679CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC®…Medtronic Sofamor Danek201786—
+6K170592NuVasive BASE Interfixated Titanium SystemNu Vasive, Incorporated2017186—