510(k) Report

Devices descending from K021791

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K130932Firebird Spinal Fixation SystemOrthofix, Inc.2013811
+5K131343Reform Pedicle Screw SystemSpinal USA201331—
+5K130279Reform Pedicle Screw SystemSpinal USA201331—
+5K122801Providence Cervical CageProvidence Medical Technology, Inc.20131—
+5K130506Imse P-TlifInstitute of Musculoskeletal Science & Education20130—
+5K131030Range Spinal SystemK2m, Inc.201334—
+5K130330Range Spinal SystemK2m, Inc.201336—
+5K130306Incite Anchored Cervical Interbody DeviceIncite Innovation, LLC20131—
+5K123487Gso GS1 Cannulated Screw SystemGold Standard Orthopaedics, LLC20130—
+5K123993Solus Anterior Lumbar Interbody Fusion (Alif) SystemAlphatec Spine, Inc.20130—
+5K122872Intervertebral Body Fusion DeviceDio Medical Co., Ltd.201316—
+5K123656Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc.201339—
+5K123412Range Spinal System, Small Strature ComponentsK2m, Inc.201334—
+5K123134Easyspine SystemLdr Spine USA, Inc.20131—
+5K120603Varilift -CWenzel Spine2013193—
+5K123281Acculif TL-Peek CageCoalign Innovations, Inc.2013146—
+5K123752Acculif TL and PL CageCoalign Innovations, Inc.2013676—
+5K121254Camber Spine Technologies TLS 5.0 Inerbody CageCamber Spine Technologies201340—
+5K121649Construx Mini Peek TI Spacer SystemOrthofix2012289—
+5K123246CD Horizon Spire Z Spinal SystemMedtronic Sofamor Danek20122—
+5K121151Pro-Link Cervical Spacer SystemLife Spine, Inc.2012116—
+5K122956Fuselox Lumbar Interbody Fusion DeviceCaptiva Spine20122—
+5K1217414-Web Cervical STS (Spinal Truss System)4-Web, Inc.201235—
+5K122226Revere Stabilization SystemGlobus Medical, Inc.2012225—
+5K122021Sterispine LC CageSafe Orthopaedics20122—
+5K120819Stalif CCentinel Spine, Inc.2012206—
+5K121922Beacon Stabilization SystemGlobus Medical, Inc.20129—
+5K121107Fortify Integrated Corpectomy Spacers, (Fortify I and Fortify I-R)Globus Medical, Inc.2012214—
+5K113796Solitaire-C Cervical Spacer SystemEbi, LLC20121421
+5K112459Synthes Zero-PSynthes Spine Co.Lp2011277—
+5K112068Synthes Zero-P Variable Angle (VA)Synthes Spine Co.Lp2011331
+5K111439Chesapeake (Cervical Components)K2m, Inc.20113451
+5K111122Aesculap Sibd XP Spinal SystemAesculap Implant Systems, Inc.2011460—
+5K111675VU C*Pod Intervertebral Body Fusion DeviceTheken Spine, LLC201162—
+5K110522Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc.2011106—
+5K102323Cervical Standalone Intervertebral Body Fusion DeviceTheken Spine, LLC201062—
+5K101288Staxx XD SystemSpine Wave, Inc.201051
+5K094042Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek2010397—
+5K100043Coroent XLR Standalone SystemNuvasive, Inc.2010744—
+5K091301Life Spine Stand-Alone Spacer SystemLife Spine2009473—
+5K093434Vertex Reconstruction System and Vertex Select Reconstruction SystemMedtronic Sofamor Danek20097—
+5K082270Octane Vertebral Body Replacement (VBR) SystemVertiflex, Inc.200855—
+5K073420Blackstone Ascent Multiaxial ScrewsBlackstone Medical, Inc.20089—
+6K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+6K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+6K262489BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20260—
+6K261810Vertiwedge® Intraosseous SystemFoundation Surgical Group20260—
+6K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+6K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+6K261430TruLift Expandable SystemLife Spine, Inc.20260—
+6K253943Tiger 2 SystemZavation Medical Products, LLC20260—
+6K2530413d Cage CervicalFims Co., Ltd.20260—
+6K262094E3D™-C Interbody SystemEvolution Spine20260—
+6K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+6K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+6K253921VERTICALE® Navigation InstrumentsSilony Medical GmbH20260—
+6K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+6K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+6K260286Dynamo™ Spinal Cement; Salvo® Spine SystemSpine Wave, Inc.20260—
+6K253195TAURUS Posterior Occipital-Cervico-Thoracic Spinal SystemsZheJiang Decans Medical Devices Co., Ltd.20260—
+6K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+6K253894BMD Titanium Spinal Fusion SystemGlobal Biomedica s.r.o.20260—
+6K261374LigaPASS™ SystemMedicrea International S.A.S20260—
+6K260837VersaLift Expandable SystemLife Spine, Inc.20260—
+6K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+6K261067BEE PLIF CageNGMedical GmbH20260—
+6K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+6K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20260—
+6K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+6K252774Uni-C Cervical Cage SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+6K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine20260—
+6K252432Flex-Z™ Cervical CageSpinepoint, LLC20260—
+6K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+6K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+6K253559Ventana™ A Anterior Lumbar Interbody SystemSpinal Elements, Inc.20260—
+6K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+6K253545Vulcan Spinal SystemK2m, Inc.20260—
+6K260038E3D™-C Interbody SystemEvolution Spine20261—
+6K253748Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer SystemLife Spine, Inc.20260—
+6K252885OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20260—
+6K252461Swedge™ Pedicle Screw Fixation System Bezier RodSpinal Resources, Inc.20260—
+6K253266Titanium Interbody SystemSpine Innovation, LLC20260—
+6K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+6K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+6K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+6K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+6K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20252—
+6K253093Vital™ Spinal Fixation SystemHighridge Medical, LLC20250—
+6K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc.20250—
+6K250764SpineLinc Anterior Cervical Implant SystemLincotek Medical20250—
+6K252610ZSFab Lumbar Interbody SystemZsfab, Inc.20251—
+6K250769Dakota LP SystemPrecision Spine, Inc.20250—
+6K250560BEE HANGMedical GmbH20250—
+6K252742Navigated InstrumentsTyber Medical, LLC20251—
+6K253129Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20250—
+6K253377Expandable Titanium PLIF/TLIF SystemSpectrum Spine, Inc.20250—
+6K253249TriALTIS™ Spine SystemMedos International SARL20251—
+6K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+6K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+6K250076Endeavor™ Stand-Alone Cervical IBF SystemInnovasis20250—