510(k) Report

Devices descending from K040422

1,002 later devices reach Modification to Verte-Stack through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K182885Atlantis™ Anterior Cervical Plate, Divergence™ Anterior Cervical Fusion System, Premier™…Medtronic Sofamor Danek USA, Inc.20198—
+7K182477Cervical SpacerAdditive Implants, LLC201915—
+7K180230NEST Interbody SystemPaonan Biotech Co., Ltd.20191—
+7K182284Tyber Medical PT Interbody SpacerTyber Medical, LLC20195—
+7K182210TiWAVE-L Porous Titanium Lumbar CageKalitec Medical, LLC20193—
+7K182584Lucent® XPSpinal Elements, Inc.20183—
+7K181357PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc.201897—
+7K180550NuVasive Monolith Cervical Corpectomy SystemNu Vasive, Incorporated201811—
+7K181590Neurostructures Cavetto® [MAX] Cervical Cage SystemNeurostructures, Inc.20180—
+7K181837Spinal Elements Ti-Bond coated devicesSpinal Elements, Inc.201898—
+7K181818Scarlet AL-TSpineart201864—
+7K181397DualXInnovasive, Inc.201815—
+7K181386NuVasive Brigade Lateral SystemNu Vasive, Incorporated2018158—
+7K180076Ti 3Z Interbody SystemZavation Medical Products, LLC20184—
+7K181350ASTRA-OCT Spine SystemSpinecraft, LLC20180—
+7K181203Juliet TiSpineart20181—
+7K180401TiWAVE-C™ Porous Titanium Cervical CageKalitec Direct, LLC20185—
+7K173892NuVasive® XLX Interbody SystemNu Vasive, Incorporated2018115—
+7K173082Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20185—
+7K180056Genesys Spine AIS-C Cervical Anchored Interbody SystemGenesys Spine201818—
+7K173535Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TAS Hyperlordotic Interbody…Titan Spine, LLC20181052
+7K171312FortiCore®Nanovis, LLC20183—
+7K173702Juliet Ti LLSpineart20182—
+7K172083Idys™ ALIF SystemClariance, Sas20177—
+7K172123NuVasive® Modulus XLIF Interbody SystemNu Vasive, Incorporated2017227—
+7K171633NuVasive TLX Interbody SystemNu Vasive, Incorporated2017251—
+7K171496Tritanium C Anterior Cervical CageStryker Spine2017129—
+7K171567IRIX-A Lumbar Integrated Fusion SystemX-Spine Systems, Inc.201701
+7K171140Matrixx SystemNexxt Spine, LLC2017145—
+7K170851Anterior Spine Truss System (STS) Interbody Fusion Device4Web, Inc.20175—
+7K171630LumFuse-TPPrecifit Medical, Ltd.20171—
+7K170399Endoskeleton TO Interbody Fusion Device (IBD)Titan Spine, LLC2017105—
+7K170830Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20175—
+7K170962NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated2017304—
+7K170961NuVasive CoRoent Small Interlock II SystemNu Vasive, Incorporated201718—
+7K163707NuVasive CoRoent Ti-C SystemNu Vasive, Incorporated201719—
+7K170592NuVasive BASE Interfixated Titanium SystemNu Vasive, Incorporated2017186—
+7K170055CAPRI Corpectomy Cage SystemK2m201711—
+7K170243LOSPA IS TLIF & DLIF CagesCorentec Co., Ltd.20170—
+7K163230NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2017276—
+7K163364MOJAVE Expandable Interbody SystemK2m201725—
+7K161032neon3™ universal OCT spinal stabilizationUlrich GmbH & Co. KG201671
+7K162680SOVEREIGN® Spinal SystemMedtronic Sofamor Danek USA, Inc.201631—
+7K161993Leva® Anterior Interbody SystemSpine Wave, Inc.20160—
+7K160959Xsert Lumbar Expandable Interbody SystemX-Spine Systems, Inc.201612—
+7K162262Tritanium® PL CageStryker2016132—
+7K161379ELSA SpacersGlobus Medical, Inc.2016155—
+7K161442NuVasive® CoRoent® Small Interlock™ SystemNu Vasive, Incorporated201694—
+7K161173Avenue® T TLIF CageLdr Spine USA, Inc.20163—
+7K162264Cascadia Interbody SystemK2m, Inc.2016169—
+7K161485Nanovis Intervertebral Body Fusion System and Forticore (R)Nanovis, LLC20165—
+7K160066Pro-Link® Stand-Alone Cervical Spacer SystemLife Spine, Inc.20163—
+7K160955Tritanium® PL CageStryker2016178—
+7K152622Alta ACDF SystemBiomet Spine20160—
+7K160715AccuLIF TL and PL CageStryker Corporation20160—
+7K160874Nanovis Intervertebral Body Fusion System and FortiCore®Nanovis, LLC20164—
+7K143578SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers…Globus Medical, Inc.2016210—
+7K153419NuVasive CoRoent Thoracolumbar SystemNu Vasive, Incorporated2016400—
+7K153495Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T…Ldr Spine USA20161891
+7K153250Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies201632—
+7K151939COALITION SpacersGlobus Medical, Inc.2016152—
+7K151310Amendia Interbody Fusion DevicesAmendia, Inc.2016169—
+7K151481Sahara Stabilization SystemK2m, Inc.20155—
+7K143479Bluefin Interbody SystemTides Medical20152—
+7K140734Nextgen Altius Oct SystemEbi, LLC20140—
+7K142299CoRoent Small Interlock SystemNu Vasive, Incorporated201499—
+7K142450DIVERGENCE Anterior Cervical Fusion SystemMedtronic Sofamor Danek USA, Inc.20146—
+7K140280ForticoreNanovis, LLC20149—
+7K141005Z-Link CervicalZavation, LLC20144—
+7K133556Virage Oct Spinal Fixation SystemZimmer Spine, Inc.2014272
+7K132894Optio-C Anterior Cervical SystemZimmer Spine, Inc.201424—
+7K131429Reliance Cervical Ibf SystemReliance Medical Systems, LLC201324—
+7K121877Gibralt Occipital Plate Screws, Set Screw, Gibralt Occipital System Articulating Rod…Exactech, Inc.20134—
+7K122378Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC)201271
+7K113593Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC)2012102—
+7K113346Neon SystemUlrich GmbH & Co. KG20121—
+7K111076Solanas Avalon Posterior Fixation SystemAlphatec Spine, Inc.20115—
+8K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+8K263049SABER-C SystemElevation Spine20260—
+8K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+8K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+8K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+8K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+8K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+8K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+8K261060Navigated LLIF Impactable TrackerTyber Medical, LLC20260—
+8K260837VersaLift Expandable SystemLife Spine, Inc.20260—
+8K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+8K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+8K260340HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC…HC Biologics, LLC20260—
+8K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine20260—
+8K253583LUX Expandable Lumbar Interbody SystemXenix Medical20260—
+8K253158VyBrate™ VBR SystemVy Spine, LLC20260—
+8K252610ZSFab Lumbar Interbody SystemZsfab, Inc.20251—
+8K252686EffortMed PEEK Cages & Corpectomy CagesEffortmed, LLC20251—
+8K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+8K252322SIros-X SystemGenesys Spine20250—
+8K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+8K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+8K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—