510(k) Report

Devices descending from K010930

2,053 later devices reach Lift VB Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K193541NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2020157—
+5K193100RESPONSE™ Spine System, RESPONSE™ 4.5/5.0 Spine System, RESPONSE™ 5.5/6.0 Spine SystemOrthoPediatrics Corp.20204—
+5K193011CD Horizon™ Fenestrated Screw SetMedtronic Sofamor Danek USA, Inc.202041—
+5K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine20207—
+5K190881Spinal Elements Navigated InstrumentsSpinal Elements, Inc.20194—
+5K182987Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20199—
+5K192026Peridot Intervertebral body fusion SystemGbs Commonwealth Co., Ltd.20196—
+5K190544XIHPOS™ ZFUZE™ Interbody Fusion SystemDifusion Technologies20190—
+5K190636NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201913—
+5K192214CarboClear VBR SystemCarboFix Orthopedics, Ltd.20191—
+5K191822Nano FortiCore, FortiCoreNanovis, LLC20192—
+5K191212CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated…Medos International SARL20190—
+5K191576Mercury® Spinal System, Overwatch® Spinal SystemSpinal Elements, Inc.20195—
+5K190398Republic Spine Restore Intervertebral Body Fusion SystemRepublic Spine, LLC20190—
+5K191354Ti3Z Cervical Interbody SystemZavation Medical Products, LLC201913—
+5K183243Velofix TLIF CageU&I Corporation20190—
+5K190959ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2019108—
+5K190360LineSider™ Spinal SystemIntegrity Implants, Inc.201913—
+5K190889Republic Spine Restore Cervical Interbody Fusion SystemRepublic Spine, LLC20190—
+5K183630SPINEART Navigation Instrument SystemSpineart SA20196—
+5K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC201993—
+5K183381Navigation Enabled InstrumentsStryker20191—
+5K182877HALF DOME Posterior Lumbar Interbody SystemAstura Medical, LLC201921—
+5K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+5K182477Cervical SpacerAdditive Implants, LLC201915—
+5K182982BridalVeil Navigated InstrumentsAstura Medical20190—
+5K183239CoreLink F3D™ Lateral SystemCorelink, LLC20188—
+5K181899Roccia® PlifSilony Medical GmbH20180—
+5K181357PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc.201897—
+5K181970MectaLIF Posterior ExtensionMedacta International S.A.20182—
+5K181860NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2018159—
+5K181295Genesys Spine AIS-C Cervical Stand-Alone SystemGenesys Spine201817—
+5K180814CoreLink® M3™ Stand-Alone Anterior Lumbar SystemCorelink, LLC201818—
+5K180556Corelink Foundation 3D Anterior Lumbar SystemCorelink, LLC20185—
+5K173947Lumbar Interbody Fusion System (OLLIF)Advanced Research Medical, LLC201801
+5K181030Rubicon Lumbar Interbody Fusion SystemRubicon Spine, LLC20180—
+5K172166OLYMPIC Navigated InstrumentsAstura Medical20185—
+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—
+5K172105The Plateau-LO Spacer SystemLife Spine, Inc.20181—
+5K172185Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20177—
+5K172330Blustone Synergy Silica SystemBlustone Synergy20170—
+5K173182ProLift® Expandable SystemLife Spine, Inc.201737—
+5K170389TAURUS PEEK Cage SystemMedyssey USA, Inc.20170—
+5K172009Cascadia Interbody SystemK2m, Inc.2017433
+5K172419Velofix™ TLIF CageU&I Corporation20172—
+5K173148ACIFColigne AG20171—
+5K163595IMPIX 3D Print CagesMedicrea International SA2017282
+5K172328SOVEREIGN™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201730—
+5K172341NuVasive® Modulus TLIF Interbody SystemNu Vasive, Incorporated2017163—
+5K163366Shanghai Sanyou CARMEN Cervical Fusion SystemShanghai Sanyou Medical Co, Ltd.20170—
+5K170119Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc.201711
+5K171633NuVasive TLX Interbody SystemNu Vasive, Incorporated2017251—
+5K171107CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal SystemMedtronic Sofamor Danek USA, Inc.20178—
+5K171893Blustone Synergy Lumbar Interbody Fusion System (Basalt, Magma, Obsidian), Blustone…Bluestone Synergy20172—
+5K171321K2M Navigation InstrumentsK2m201711
+5K171140Matrixx SystemNexxt Spine, LLC2017145—
+5K171656Genesys Spine Apache Interbody Fusion SystemGenesys Spine20170—
+5K171749Velofix (tm) Interbody Fusion SystemU&I Corporation20175—
+5K170844Gemini-C Hybrid Cervical Interbody SystemOsseus Fusion Systems, LLC20170—
+5K170297Tranquil Interbody SystemNexus Spine, LLC201715—
+5K163494Summit Spine Channel Cervical Interbody Fusion SystemSummit Spine20171—
+5K171468FUSE Spinal SystemMedtronic Sofamor Danek20170—
+5K170679CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC®…Medtronic Sofamor Danek201786—
+5K163581Navigated ELEVATE Inserter, Navigated Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.2017103—
+5K162206Zavation IBFZavation, LLC201724—
+5K170347CD HORIZON™ Fenestrated Screw SetMedtronic Sofamor Danek USA201791—
+5K170243LOSPA IS TLIF & DLIF CagesCorentec Co., Ltd.20170—
+5K163230NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2017276—
+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—
+5K160663Lumbar Interbody Fusion System (ALIF, PLIF, LLIF, TPLIF)Evolution Spine, LLC20160—
+5K162379CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.201645—
+5K161438Genesys Spine Apache® Anterior Lumbar Interbody Fusion SystemGenesys Spine201611—
+5K161842Overwatch Spine SystemAmendia, Inc.201661
+5K162494CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.201627—
+5K161379ELSA SpacersGlobus Medical, Inc.2016155—
+5K153665Prow Fusion-LNlt Spine, Ltd.20160—
+5K161627PASS LP Spinal SystemMedicrea International SA20167—
+5K152099Genesys Spine Apache® Anchored Cervical Interbody Fusion SystemGenesys Spine201619—
+5K161404Genesys Spine Apache® Lateral Lumbar Interbody Fusion SystemGenesys Spine201610—
+5K153621Juliet® TiSpineart2016751
+5K161223TransContinental® M Spacers and InterContinental® Plate-SpacersGlobus Medical, Inc.2016117—
+5K153786Prow Fusion-VNlt Spine, Ltd.20166—
+5K160874Nanovis Intervertebral Body Fusion System and FortiCore®Nanovis, LLC20164—
+5K161363Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201675—
+5K160989NuVasive® Reline® SystemNu Vasive, Incorporated201667—
+5K153436LATERAL Spine Truss System4Web, Inc.20165—
+5K160154ALTA Anterior Cervical Interbody SpacerAstura Medical201663—
+5K160324Cervical Interbody Fusion SystemEvolution Spine, LLC20162—
+5K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A.20162—
+5K153782NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated2016390—
+5K153627NuVasive® TLX Interbody SystemNu Vasive, Incorporated2016252—
+5K151665SUSTAIN Additional ImplantsGlobus Medical, Inc.2016119—
+5K153438PERIMETER C (Titanium) Spinal SystemMedtronic Sofamor Danek USA, Inc.20160—
+5K153442CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with…Medtronic Sofamor Danek USA, Inc.201684—