510(k) Report

Devices descending from K031780

1,326 later devices reach Verte-Stack Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K201605EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF Cage, EIT Cellular…Eit Emerging Implant Technologies GmbH2020130—
+7K193172Luna XD Ti Interbody Fusion SystemBenvenue Medical, Inc.20201—
+7K200879SeaSpine Meridian System, SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation202060—
+7K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+7K200816SpineEX Sagittae Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20201—
+7K192646SYMPHONY™ OCT SystemMedos International SARL20202—
+7K193541NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2020157—
+7K200048MectaLIF Anterior SimpleMedacta International S.A.20200—
+7K193506NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR SystemNu Vasive, Incorporated20201—
+7K193255Largo PEEK Interbody SystemFlospine, LLC20201—
+7K193359SureMAX Family of Cervical SpacersAdditive Implants, Inc.202014—
+7K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+7K192582NuVasive CoRoent Small Interlock SystemNu Vasive, Incorporated201930—
+7K191584FORTICO Anterior Cervical Fixation SystemCamber Spine Technologies, LLC20192—
+7K192434DualX Lumbar Intervertebral Body Fusion DeviceAmplify Surgical, Inc.20190—
+7K191822Nano FortiCore, FortiCoreNanovis, LLC20192—
+7K191537eCarbon IBDsBack 2 Basics Direct, LLC20193—
+7K191778Omnia Medical VBROmnia Medical, LLC20195—
+7K190870Cervical Spinal Truss System-Stand Alone (CSTS-SA)4Web, Inc.201910—
+7K190680Favo S-TlifSilony Medical GmbH20190—
+7K182139AXTi Titanium Stand-Alone ALIF SystemInnovasis, Inc.201972—
+7K182608Oyster ACIF CageSilony Medical GmbH20190—
+7K183426MectaLIF Anterior Stand Alone ExtensionMedacta International S.A.20191—
+7K190322SCARLET® AC-T Secured Anterior Cervical CageSpineart20191—
+7K190193SpineEX Sagittae® Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20192—
+7K182477Cervical SpacerAdditive Implants, LLC201915—
+7K182007Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies20180—
+7K182746ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc.2018110—
+7K181590Neurostructures Cavetto® [MAX] Cervical Cage SystemNeurostructures, Inc.20180—
+7K181621Stable-C Interbody SystemNexus Spine, LLC20187—
+7K181644EIT Cellular Titanium® Lumbar Cage LLIFEit Emerging Implant Technologies GmbH2018141—
+7K181295Genesys Spine AIS-C Cervical Stand-Alone SystemGenesys Spine201817—
+7K181483Tranquil Interbody SystemNexus Spine, LLC20186—
+7K180990TirboLOX-L Lumbar IBFDCaptiva Spine, Inc.20181—
+7K181453ATEC ALIF Spacer SystemAlphatec Spine, Inc.2018111—
+7K181014Tritanium PL CageStryker Spine2018137—
+7K181079SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation201863—
+7K181350ASTRA-OCT Spine SystemSpinecraft, LLC20180—
+7K180480ATEC Universal Spacer SystemAlphatec Spine, Inc.2018113—
+7K180078Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF SystemInnovasis, Inc.2018551
+7K173606SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu…SeaSpine Orthopedics Corporation201859—
+7K171495Zyston Strut Open Titanium Spacer SystemZimmer Biomet Spine, Inc.20181—
+7K173025NuVasive® MLX® – Medial Lateral Expandable Lumbar Interbody System; NuVasive® AP…Nu Vasive, Incorporated20188—
+7K171312FortiCore®Nanovis, LLC20183—
+7K173102Reliance Cervical IBF SystemReliance Medical Systems, LLC201715—
+7K171434ROCCIA® MultiLIFSilony Medical GmbH20174—
+7K173182ProLift® Expandable SystemLife Spine, Inc.201737—
+7K172009Cascadia Interbody SystemK2m, Inc.2017433
+7K172676NuVasive® Modulus-C Interbody SystemNu Vasive, Incorporated2017125—
+7K173153Vertera Spine™ Coalesce™ Thoracolumbar Interbody Fusion SystemNu Vasive, Incorporated2017160—
+7K173260SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica…SeaSpine Orthopedics Corporation201767—
+7K172253Altus Spine Cervical Interbody Fusion SystemAltus Partners, LLC20170—
+7K172341NuVasive® Modulus TLIF Interbody SystemNu Vasive, Incorporated2017163—
+7K171686Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) SystemChoicespine2017116—
+7K171656Genesys Spine Apache Interbody Fusion SystemGenesys Spine20170—
+7K170830Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20175—
+7K170643Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) SystemRti Surgical, Inc. Dba Rti Biologics201711—
+7K170055CAPRI Corpectomy Cage SystemK2m201711—
+7K170455MectaLIF Anterior Stand AloneMedacta International S.A.20174—
+7K163364MOJAVE Expandable Interbody SystemK2m201725—
+7K163409Rampart (TM) T Lumbar Interbody Fusion DeviceSpineology, Inc.20170—
+7K162918Atlas Spine Expandable Interbody SystemAtlas Spine, Inc.201729—
+7K162879Elite Expandable Interbody Fusion DeviceSpineology, Inc.20179—
+7K161032neon3™ universal OCT spinal stabilizationUlrich GmbH & Co. KG201671
+7K161993Leva® Anterior Interbody SystemSpine Wave, Inc.20160—
+7K162431Luna 3D Interbody Fusion SystemBenvenue Medical, Inc.20163—
+7K162138NuVasive CoRoent Small Ti-C SystemNu Vasive, Incorporated2016135—
+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—
+7K153786Prow Fusion-VNlt Spine, Ltd.20166—
+7K160874Nanovis Intervertebral Body Fusion System and FortiCore®Nanovis, LLC20164—
+7K153123Genesys Spine Apache Interbody Fusion SystemGenesys Spine201612—
+7K153627NuVasive® TLX Interbody SystemNu Vasive, Incorporated2016252—
+7K151939COALITION SpacersGlobus Medical, Inc.2016152—
+7K151312VerteLP Interbody Fusion DeviceVgi, LLC201601
+7K151481Sahara Stabilization SystemK2m, Inc.20155—
+7K151322Amendia Interbody Fusion DevicesAmendia, Inc.20152261
+7K150994NuVasive CoRoent Thoracolumbar ImplantsNu Vasive, Incorporated2015402—
+7K142269Reliance Cervical IBF SystemReliance Medical Systems, LLC201523—
+7K150643Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-TiCentinel Spine, Inc.2015368—
+7K143595NuVasive (R) CCX-L Interbody SystemNu Vasive, Incorporated2015253—
+7K143228Ancora LLC Interbody Fusion DeviceFrontier Medical Devices, Inc.20150—
+7K140734Nextgen Altius Oct SystemEbi, LLC20140—
+7K140280ForticoreNanovis, LLC20149—
+7K141005Z-Link CervicalZavation, LLC20144—
+7K133556Virage Oct Spinal Fixation SystemZimmer Spine, Inc.2014272
+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—
+8K263049SABER-C SystemElevation Spine20260—
+8K262230Mg OSTEOREVIVE™;Mg OSTEOCRETE™Bone Solutions, Inc.20260—
+8K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc.20260—
+8K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+8K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+8K261279DeltaNEC Interbody SystemNexus Spine20260—
+8K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—
+8K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—