510(k) Report

Devices descending from K021791

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K161369EVEREST Spinal SystemK2m, Incorporated20169—
+6K152622Alta ACDF SystemBiomet Spine20160—
+6K153273MySpine Pedicle Screw Placement Guides - LPMedacta International S.A.20166—
+6K152501Spinal Jaxx Interbody Fusion DeviceNeuropro Spinaljaxx, Inc.201601
+6K160926F1 MPS Modular Pedicle Screw SystemDegen Medical20161—
+6K161280Cervical Stand Alone SystemOrthofix, Inc.201614—
+6K160980Threshold Pedicular Fixation System, Palisade Pedicular Fixation SystemSpineology, Inc.20166—
+6K160226JAZZ CLAW System (hooks and rods) and JAZZ CLAW connectorImplanet, S.A.20161—
+6K160125Cascadia Interbody SystemK2m2016315—
+6K160051NuVasive® Interfixated Interbody SystemNu Vasive, Incorporated2016396—
+6K153495Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T…Ldr Spine USA20161891
+6K160547Cascadia Interbody SystemK2m2016157—
+6K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+6K153400ProLift Expandable SystemLife Spine, Inc.201672—
+6K151406Cogent Lateral Interbody SystemCogent Spine, LLC201611—
+6K160291Optimus ALIF SystemAmendia, Inc.20160—
+6K153428Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2016731
+6K153525Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine20160—
+6K151726AVS AL and AVS ALign PEEK Spacers, AVS PL and AVS UniLIF PEEK Spacers, AVS TL PEEK…Stryker Corporation20161391
+6K152475FORZA PTC Spacer SystemOrthofix, Inc.2016236—
+6K153463CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc.201587—
+6K151496Latitude-C Cervical Interbody Spacer SystemDegen Medical201513—
+6K152651AccuLIF TL and PL CageStryker Corporation201530—
+6K143222FIREFLY Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20158—
+6K152304Tritanium PL CageStryker20154481
+6K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated20152—
+6K151648Altus Spine Pedicle Screw System, Altus Spine MIS Pedicle Screw System, Valencia Pedicle…Altus Partners, LLC20155—
+6K150788Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral Body Fusion…Meditech Spine, LLC2015202—
+6K150619CONSTRUX Mini PEEK Spacer System, CONSTRUX Mini PEEK Ti Spacer SystemOrthofix, Inc.2015107—
+6K151677LnK Cervical Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20158—
+6K151488Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2015781
+6K151116CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20153—
+6K151214ALIF Interfixated SystemNu Vasive, Incorporated2015220—
+6K150521Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) SystemRti Surgical, Inc. Dba Rti Biologics201512—
+6K142487Chesapeake Stabilization SystemK2m, Inc.201571
+6K143258PLIF STS, TLIF STS, OLIF STS (Spinal Truss System)4Web, Inc.2015211—
+6K142996StaXx (R) XD SystemSpine Wave, Inc.20150—
+6K143126Renovis S141 Lumbar Interbody Cage SystemRenovis Surgical Technologies2015237—
+6K143149Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201584—
+6K141186Firebird Spinal Fixation SystemOrthofix, Inc.20153—
+6K140734Nextgen Altius Oct SystemEbi, LLC20140—
+6K142299CoRoent Small Interlock SystemNu Vasive, Incorporated201499—
+6K141942Midline II TICentinel Spine, Inc.2014459—
+6K142193Cogent Med-Lif XLCogent Spine, LLC201412—
+6K141804Polaris Spinal System - HA CoatedBiomet Spine, LLC201421—
+6K1421124WEB Spinal Implant Products4Web, Inc.201433—
+6K133813Flxfit Intervertebral Body Fusion DeviceExpanding Orthopedics, Inc.2014137—
+6K132765PFX Spinous Process Fixation SystemInnovasis, Inc.20140—
+6K133556Virage Oct Spinal Fixation SystemZimmer Spine, Inc.2014272
+6K133200Stalif C (R)Centinel Spine, Inc.201410—
+6K134038Camber Spine Diagon Oblique CageCamber Spine201428—
+6K132403Annextm Adjacent Level SystemSpine Wave, Inc.20142—
+6K131429Reliance Cervical Ibf SystemReliance Medical Systems, LLC201324—
+6K132505Acculif TL and PL CageCoalign Innovations, Inc.20136453
+6K131951Irix-C Cervical Integrated Fusion SystemX-Spine Systems, Inc.201312—
+6K131449Coalition SpacerGlobus Medical, Inc.2013235—
+6K131443Coalign Innovations Acculif XL Ibf CageCoalign Innovations, Inc.20130—
+6K130434Octane Straight, Octane Straight - Lordotic, Octane Straight I/R, Octane Straight I/R -…Exactech, Inc.201311—
+6K123045Brigade Standalone SystemNuvasive, Inc.2013696—
+6K130194Acculif XL CageCoalign Innovations, Inc.20131—
+6K123783Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol ImplantsGlobus Medical, Inc.201397—
+6K121877Gibralt Occipital Plate Screws, Set Screw, Gibralt Occipital System Articulating Rod…Exactech, Inc.20134—
+6K122378Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC)201271
+6K121852Synthes Zero-P Variable Angle (VA)Synthes Spine Co.Lp201230—
+6K113593Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC)2012102—
+6K112561Nuvasive Coroent NO-Profile SystemNuvasive, Inc.201212—
+6K113346Neon SystemUlrich GmbH & Co. KG20121—
+6K113252Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek2012306—
+6K112388Lanx Cervical SALanx, Inc.201126—
+6K111166A-Wedge Anterior Interbody System (a-Wedge a.I.S.)Spineworks, LLC201123—
+6K111076Solanas Avalon Posterior Fixation SystemAlphatec Spine, Inc.20115—
+6K102547Coroent Interlock SystemNuvasive, Inc.2011131—
+7K262726NeckTune™ SA Cervical CageMedyssey Co., Ltd.20260—
+7K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—
+7K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—
+7K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+7K261279DeltaNEC Interbody SystemNexus Spine20260—
+7K253151Fule Interbody Fusion Cage SystemBeijing Fule Science & Technology Development Co., Ltd.20260—
+7K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, Inc.20260—
+7K261060Navigated LLIF Impactable TrackerTyber Medical, LLC20260—
+7K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+7K260660SABER-C SystemElevation Spine20261—
+7K260549ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemZsfab, Inc.20260—
+7K260340HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC…HC Biologics, LLC20260—
+7K253583LUX Expandable Lumbar Interbody SystemXenix Medical20260—
+7K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+7K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+7K254061Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc.20260—
+7K253158VyBrate™ VBR SystemVy Spine, LLC20260—
+7K252686EffortMed PEEK Cages & Corpectomy CagesEffortmed, LLC20251—
+7K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+7K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+7K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+7K251444Endoskeleton™ Interbody SystemsMedtronic Sofamor Danek USA, Inc.20250—
+7K250540SABER-C SystemElevation Spine20252—
+7K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+7K250987aprevo® posterior/transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20251—
+7K243816Testa TP Pivoting Spacer SystemSpine Wave, Inc.20250—
+7K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+7K251131Annex® 2 Adjacent Level SystemSpine Wave, Inc.20250—