510(k) Report

Devices descending from K021791

2,047 later devices reach Verte-Stack Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K182954Salvo™ Spine SystemSpine Wave, Inc.20186—
+6K183080Mega Plus Spine SystemBk Meditech, Co., Ltd.20182—
+6K180550NuVasive Monolith Cervical Corpectomy SystemNu Vasive, Incorporated201811—
+6K181829Velofix TLIF CageU&I Corporation20181—
+6K182195Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20183—
+6K180980ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization SystemCamber Spine Technologies, LLC20181—
+6K182322Duo Lumbar Interbody Fusion DeviceSpineology, Inc.20182—
+6K182239OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20182—
+6K182240PASS LP Spinal SystemMedicrea International SA20182—
+6K181531SpineEX Sagittae Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20183—
+6K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+6K182377CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.201839—
+6K182345Spineology Navigation InstrumentsSpineology, Inc.20182—
+6K180215DYNA-LINK ELITE Stand-Alone Anterior Lumbar SystemLife Spine, Inc.20182—
+6K181380LnK Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.201810—
+6K173893TrabisColigne AG20180—
+6K181386NuVasive Brigade Lateral SystemNu Vasive, Incorporated2018158—
+6K180373CancelleX Porous Titanium Lumbar Interbody DeviceXenco Medical, LLC20180—
+6K180179Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird®…Orthofix, Inc.201837—
+6K180990TirboLOX-L Lumbar IBFDCaptiva Spine, Inc.20181—
+6K181453ATEC ALIF Spacer SystemAlphatec Spine, Inc.2018111—
+6K181079SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation201863—
+6K180673Normandy VBR SystemZavation Medical Products, LLC20187—
+6K181350ASTRA-OCT Spine SystemSpinecraft, LLC20180—
+6K180038NuVasive Pulse SystemNu Vasive, Incorporated20183—
+6K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+6K180401TiWAVE-C™ Porous Titanium Cervical CageKalitec Direct, LLC20185—
+6K180675Atlas Spine Expandable Cervical Interbody SystemAtlas Spine, Inc.20182—
+6K173832InTice™-C Porous Ti Cervical Interbody SystemX-Spine Systems, Inc.201801
+6K180642Pro-Link® Ti Stand-Alone Cervical Spacer SystemLife Spine, Inc.20182—
+6K180796Spineology Navigation InstrumentsSpineology, Inc.20183—
+6K180433Ennovate®Aesculap Implant Systems, LLC201811
+6K173472MySpine Pedicle Screw Placement Guides – MC and Drill Pilot InstrumentsMedacta International S.A.20185—
+6K173606SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu…SeaSpine Orthopedics Corporation201859—
+6K180376K2M Patient Specific RodsK2m, Inc.20182—
+6K173128Alamo® CAlliance Partners, LLC20182—
+6K180431Cortina [MAX] Lumbar Cage SystemNeurostructures, Inc.20181—
+6K180475CapLOX II® / TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20180—
+6K180198NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated20184—
+6K173535Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TAS Hyperlordotic Interbody…Titan Spine, LLC20181052
+6K172941CASCADIA Interbody SystemK2m201852—
+6K173159Cervical Spinal Truss System (CSTS) Interbody Fusion Device4Web, Inc.201812—
+6K173102Reliance Cervical IBF SystemReliance Medical Systems, LLC201715—
+6K171434ROCCIA® MultiLIFSilony Medical GmbH20174—
+6K173115COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and…Globus Medical, Inc.201783—
+6K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc.201721—
+6K172465Idys™ TLIF 3DTi CagesClariance, Sas20176—
+6K172888EIT Cellular Titanium® Cervical Cages, EIT Cellular Titanium® PLIF Cages, EIT Cellular…Eit Emerging Implant Technologies GmbH2017159—
+6K173260SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica…SeaSpine Orthopedics Corporation201767—
+6K172019Brisbane ALIF Device, Gladstone ALIF DeviceSignature Orthopaedics Pty, Ltd.20170—
+6K170235Lucent®Spinal Elements, Inc.2017107—
+6K172437CONSTRUX® Mini PTC Spacer System, FORZA® PTC Spacer System, PILLAR® SA PTC Spacer SystemOrthofix, Inc.2017143
+6K173095VIPER PRIME™ Screws, VIPER PRIME™ Screws with Fenestrations, EXPEDIUM® Verse Screws with…Medos International SARL201719—
+6K171489Acapella Cervical Spacer SystemChoicespine, LP201739—
+6K172724XIA® 4.5 Spinal System, Power Adaptor Instrument AccessoryStryker Corporation20179—
+6K171894NuVasive® Precept™ Spinal SystemNu Vasive, Incorporated20170—
+6K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart20179—
+6K170157INDEPENDENCE® SpacersGlobus Medical, Inc.2017109—
+6K172064Ti-Diagon Oblique TLIFCamber Spine Technologies201727—
+6K171351Posterior Spine Truss System (PSTS) Interbody Fusion Device4Web, Inc.20177—
+6K172489Reliance Cervical IBF SystemReliance Medical Systems, LLC201716—
+6K171567IRIX-A Lumbar Integrated Fusion SystemX-Spine Systems, Inc.201701
+6K171651Excelsius GPSGlobus Medical, Inc.2017691
+6K170888Renovis S141 Lumbar Interbody Fusion SystemRenovis Surgical Technologies20175—
+6K170861PremierShandong Weigao Orthopaedic Device Co., Ltd.20170—
+6K170919The TiBow Expandable Spacer SystemLife Spine, Inc.20171—
+6K171369M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20178—
+6K171630LumFuse-TPPrecifit Medical, Ltd.20171—
+6K171907Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc.2017162
+6K170399Endoskeleton TO Interbody Fusion Device (IBD)Titan Spine, LLC2017105—
+6K170830Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20175—
+6K170962NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated2017304—
+6K163506Coalesce™ (-Straight, -Convex, -Crescent, -Lateral, -Anterior, or -Oblique) Lumbar…Vertera, Inc.2017224—
+6K170569SeaSpine Shoreline ACS - Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation201782—
+6K171438Palisade™ Pedicular Fixation SystemSpineology, Inc.20171—
+6K170496Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument AccessoryStryker Corporation2017151
+6K170543VIPER PRIME™ Screws with FenestrationsMedos International SARL201748—
+6K163707NuVasive CoRoent Ti-C SystemNu Vasive, Incorporated201719—
+6K162266The Cranial Fusion SystemLife Spine, Inc.20171—
+6K170592NuVasive BASE Interfixated Titanium SystemNu Vasive, Incorporated2017186—
+6K170953Tomcat Cervical Spinal SystemChoicespine, LP2017103—
+6K163269Endoskeleton (R) TAS Interbody Fusion Device / Endoskeleton (R) TAS Hyperlordotic…Titan Spine, LLC2017143—
+6K163491NuVasive CoRoent Small Interbody SystemNu Vasive, Incorporated2017289—
+6K170455MectaLIF Anterior Stand AloneMedacta International S.A.20174—
+6K163364MOJAVE Expandable Interbody SystemK2m201725—
+6K163604SeaSpine® Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation201712—
+6K162760Spine Wave Anterior Cervical Spine SystemSpine Wave, Inc.20171—
+6K162587Roccia® AcifSilony Medical GmbH20171—
+6K160976Altus Spine Interbody Fusion SystemAltus Partners, LLC20178—
+6K162764Jazz Frame SystemImplanet, S.A.20176—
+6K161032neon3™ universal OCT spinal stabilizationUlrich GmbH & Co. KG201671
+6K162138NuVasive CoRoent Small Ti-C SystemNu Vasive, Incorporated2016135—
+6K161642CAVUX™ Cervical CageProvidence Medical Technology, Inc.20160—
+6K161442NuVasive® CoRoent® Small Interlock™ SystemNu Vasive, Incorporated201694—
+6K161173Avenue® T TLIF CageLdr Spine USA, Inc.20163—
+6K162264Cascadia Interbody SystemK2m, Inc.2016169—
+6K161081SeaSpine Shoreline ACS - Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation201683—
+6K161888JULIET® LL Lateral Lumbar CageSpineart2016145—
+6K160066Pro-Link® Stand-Alone Cervical Spacer SystemLife Spine, Inc.20163—
+6K160465Spinal Elements' Spinous Process Plate SystemSpinal Elements, Inc.20160—