510(k) Report

Devices descending from K023570

1,383 later devices reach Modification to Verte-Stack Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K172568CervagePrecifit Medical, Ltd.20181—
+5K180891EVOL Spinal Interbody System, EVOS Lumbar Interbody SystemCutting Edge Spine, LLC20181—
+5K180071STYLO Interbody Fusion DeviceLegend Spine Technologies20180—
+5K180002Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20182—
+5K180851VERTEX™ Reconstruction SystemMedtronic Sofamor Danek USA, Inc.20188—
+5K172947HALF DOME Posterior Lumbar Interbody SystemAstura Medical201822—
+5K173606SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu…SeaSpine Orthopedics Corporation201859—
+5K173082Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20185—
+5K172320Neurostructures Cavetto® Cervical Cage SystemNeurostructures, Inc.20183—
+5K173077Cavetto-SA Cervical Cage SystemNeurostructures, Inc.201821—
+5K172816TiGer Shark™ SystemChoicespine, LP201859—
+5K173702Juliet Ti LLSpineart20182—
+5K172185Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20177—
+5K171434ROCCIA® MultiLIFSilony Medical GmbH20174—
+5K172926SeaSpine Vu cPOD, Zuma-C, Complete CervicalSeaSpine Orthopedics Corporation201761—
+5K172756Varian cageMedyssey USA, Inc.20171—
+5K172419Velofix™ TLIF CageU&I Corporation20172—
+5K173260SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica…SeaSpine Orthopedics Corporation201767—
+5K170235Lucent®Spinal Elements, Inc.2017107—
+5K163595IMPIX 3D Print CagesMedicrea International SA2017282
+5K162315FORTIFY Corpectomy SpacersGlobus Medical, Inc.201755—
+5K172083Idys™ ALIF SystemClariance, Sas20177—
+5K172446SPIRA-C Open Matrix Cervical InterbodyCamber Spine Technologies20176—
+5K172392Lateral Spinal Truss System (LSTS) Interbody Fusion Device4Web, Inc.20171—
+5K172065Scarlet AC-TSpineart20172—
+5K172587Mecta-C with titanium markers and Mecta-C TiPEEK with titanium markersMedacta International S.A.20170—
+5K171351Posterior Spine Truss System (PSTS) Interbody Fusion Device4Web, Inc.20177—
+5K171496Tritanium C Anterior Cervical CageStryker Spine2017129—
+5K163375INFINITY™ OCT SystemMedtronic Sofamor Danek USA, Inc.2017165
+5K171657ShurFit 2C Lumbar Interbody Fusion SystemPrecision Spine, Inc.20174—
+5K170851Anterior Spine Truss System (STS) Interbody Fusion Device4Web, Inc.20175—
+5K171749Velofix (tm) Interbody Fusion SystemU&I Corporation20175—
+5K170550Coveris Cervical Cage SystemCamber Spine Technologies20171—
+5K170318NeoFuse Ti3D PLIF/TLIF/Cervical InterbodyHt Medical, LLC201749—
+5K170962NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated2017304—
+5K162212Divergence-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc.201757—
+5K163670Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20173—
+5K163707NuVasive CoRoent Ti-C SystemNu Vasive, Incorporated201719—
+5K170592NuVasive BASE Interfixated Titanium SystemNu Vasive, Incorporated2017186—
+5K163581Navigated ELEVATE Inserter, Navigated Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.2017103—
+5K170271NuVasive (r) Monolith Corpectomy SystemNu Vasive, Incorporated201712—
+5K152022SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION®…Globus Medical, Inc.2017149—
+5K1624024CIS® Marlin ACIF Cage SystemSolco Biomedical Co., Ltd.20171—
+5K162531Sterispine CCSafe Orthopaedics20160—
+5K162446FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK…Orthofix, Inc.20166—
+5K162003IMSE Cervical CageThe Institute of Musculoskeletal Science & Education20160—
+5K162358T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution SystemSynthes USA Products, LLC2016127—
+5K162138NuVasive CoRoent Small Ti-C SystemNu Vasive, Incorporated2016135—
+5K161129Pillar SA PTCOrthofix, Inc.201619—
+5K161485Nanovis Intervertebral Body Fusion System and Forticore (R)Nanovis, LLC20165—
+5K160605MectaLIF Anterior Stand-AloneMedacta International201610—
+5K160631Keos Lumbar IBFDKeos20161—
+5K160874Nanovis Intervertebral Body Fusion System and FortiCore®Nanovis, LLC20164—
+5K153615NeoFuse HA Enhanced PLIF/TLIFHt Medical, LLC201650—
+5K160522White Pearl Preferred Angle Anterior Cervical PlateOsseus Fusion Systems, LLC20160—
+5K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+5K160051NuVasive® Interfixated Interbody SystemNu Vasive, Incorporated2016396—
+5K143578SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers…Globus Medical, Inc.2016210—
+5K152355Twin Peaks Lumbar Interbody Fusion SystemSpineway20151—
+5K151773CONCORDE Bullet Lumbar Interbody SystemMedos International SARL2015201—
+5K152277PIVOX (tm) Oblique Lateral Spinal SystemMedtronic Sofamor Danek USA, Inc.2015190—
+5K143450Ackermann Intervertebral Body Fusion DeviceAckermann Instrumente GmbH20150—
+5K151756Sterispine LC CageSafe Orthopaedics20150—
+5K151140LnK Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.201529—
+5K151128CAPSTONE Spinal System, CLYDESDALE Spinal SystemMedtronic Sofamor Danek USA, Inc.2015255—
+5K142645Avenue T TLIF CageLdr Spine USA, Inc.2015191—
+5K142744Mecta-C TiPEEKMedacta International201512—
+5K142218Coalition AGX Plate and Coalition AGX SpacerGlobus Medical, Inc.2015155—
+5K143616AccuLIF TL and PL CageStryker Corporation20154694
+5K142940Endoskeleton TCS SystemTitan Spine, LLC20151112
+5K142152Construx Mini Peek; Spacer System, TI Spacer System, Cervical Stand Alone SystemOrthofix, Inc.2015280—
+5K141896Coroent SystemNu Vasive, Incorporated2014480—
+5K142066Aero-LL Lumbar Cage SystemStryker Corporation20142—
+5K142101Abacus (TM) Spacer SystemSpine Wave, Inc.20140—
+5K142450DIVERGENCE Anterior Cervical Fusion SystemMedtronic Sofamor Danek USA, Inc.20146—
+5K133577Clydesdale (R) Spinal SystemMedtronic Sofamor Danek USA, Inc.2014256—
+5K133717Longbow Spacer SystemLife Spine20149—
+5K140280ForticoreNanovis, LLC20149—
+5K133494Chesapeake Spinal SystemK2m, Inc.2014330—
+5K132852Peek Cage for the Vertebral SpineNeoortho Produtos Ortopedicos S/A20140—
+5K140709Skyhawk Interbody Fusion SystemOrthofix, Inc.20147—
+5K132999Cervical Stand Alone SystemOrthofix, Inc.2014281—
+5K132596Proposed OptimusCustom Spine, Inc.201451
+5K133557Juliet LL Lateral Lumbar CageSpineart2014147—
+5K132421Aesculap Peek XP Spinal Implant SystemAesculap Implant Systems, Inc.201414—
+5K133207Staxx (R) SystemSpine Wave, Inc.20131—
+5K130573Tyber Medical Interbody System; Acif, Alif, Plif, Tlif, DlifTyber Medical, LLC2013251—
+5K131888T2 XVBR Spinal System, T2 Altitude Expandable Corpectomy DeviceMedtronic Sofamor Danek, Inc.20130—
+5K122588Vusion CS PlusOrtho Development Corp.2013206—
+5K123909Aesculap Cespace XPAesculap Implant System, Inc.20137—
+5K123656Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc.201339—
+5K121649Construx Mini Peek TI Spacer SystemOrthofix2012289—
+5K121683Acculif TL CageCoalign Innovations, Inc.2012682—
+5K121107Fortify Integrated Corpectomy Spacers, (Fortify I and Fortify I-R)Globus Medical, Inc.2012214—
+5K111820Synster Cervical Cage, Alif Cage, Plif Cage, Ptlif Cage, Tlif CageBm Korea Co., Ltd.201220—
+5K113478Plif CageEisertech, LLC2012269—
+5K112459Synthes Zero-PSynthes Spine Co.Lp2011277—
+5K112068Synthes Zero-P Variable Angle (VA)Synthes Spine Co.Lp2011331
+5K110915Cervical CageEisertech, LLC201123—
+5K110864Biospine VBR SystemAesculap Implant Systems, LLC201149—