510(k) Report

Devices descending from K031780

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K232530Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemNexus Spine, LLC20235—
+6K223869ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20232—
+6K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+6K222988neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D CervicalHt Medical D.B.A. Xenix Medical20232—
+6K230607SPICCA Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+6K230608SPICCA Stand-Alone Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+6K231808QUASAR Standalone ACIF SystemGS Medical Co., Ltd.20230—
+6K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+6K231241NanoHive Medical Lumbar Interbody SystemNanoHive Medical, LLC20230—
+6K231252Ventana™ L Spinal SystemSpinal Elements, Inc.20231—
+6K230894NuVasive Modulus ALIF SystemNu Vasive, Incorporated20234—
+6K230731Zavation ALIF SystemZavation Medical Products, LLC20232—
+6K230851Kodiak Lumbar Spacer SystemMet One Technologies, LLC20230—
+6K223335SIRION Lateral Lumbar Interbody SystemAstura Medical20230—
+6K220513NITRO Interbody Fusion Cage System FamilyCtl Medical Corporation20230—
+6K223326Axiom PSR SystemRestor3D202301
+6K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+6K223043The Integrity Spine Core SystemIntegrity Spine20230—
+6K223418DeGen Impulse AM™ SystemDegen Medical20236—
+6K213030Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc.20233—
+6K223146EVOLUTION SPINE Interbody SystemEvolution Spine20239—
+6K220296Manta Ray TDF SpacerSeaSpine Orthopedics Corporation20231—
+6K222554EL CAPITAN Anterior Lumbar Interbody FusionAstura Medical20235—
+6K223190Hive™ Standalone Cervical SystemNanoHive Medical, LLC20225—
+6K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc.20221—
+6K222009aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.202212—
+6K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—
+6K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+6K220334MONET Anterior Cervical Plate SystemCtl Medical Corporation20220—
+6K221719ABTross ALIF Expandable Cage SystemAegis Spine, Inc.20222—
+6K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+6K221936Standalone ALIF Interbody Fusion SystemEminent Spine20222—
+6K211892ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages)Arftx Medical, LLC20222—
+6K222383Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX Stealth (TM)…Medtronic Sofamor Danek USA, Inc.20220—
+6K213641MONDRIAN ALIF Cage with Supplementary Fixation PlateCtl Medical Corporation20221—
+6K221844TDM Lumbar Interbody Fusion Cage SystemTdm Co., Ltd.20221—
+6K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+6K222082aprevo® anterior and lateral lumbar interbody fusion devices, aprevo® transforaminal…Carlsmed, Inc.202211—
+6K213791Unispace SA Cervical CageEdisoninno Co., Ltd.20222—
+6K220478NuVasive MOD-EX XLIF Interbody System, NuVasive MOD-EX XLIF Plated 2.0 Interbody SystemNu Vasive, Incorporated20222—
+6K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+6K212450Keos Anterior Cervical Interbody Fusion Device SystemKeos20220—
+6K220581Zavation eZspand Interbody SystemZavation Medical Products, LLC20224—
+6K220115ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion SystemMiRus, LLC20220—
+6K220711SeaSpine Meridian System, SeaSpine Meridian Anterior Plate SystemSeaSpine Orthopedics Corporation202210—
+6K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+6K212126MediExpand Cervical Expandable VBR SystemCmf Medicon Surgical, Inc.20220—
+6K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+6K214047EL CAPITAN Anterior Lumbar Interbody Fusion SystemAstura Medical20223—
+6K213980Peridot Spinal Interbody SystemGbs Commonwealth Co., Ltd.20224—
+6K211320CAPRI Corpectomy Cage SystemK2m, Inc.20222—
+6K212358Romero Cervical CageSpineup, Inc.20226—
+6K212980Tesera-k ALIF SystemKyocera Medical Technologies, Inc.20222—
+6K213951FORZA XP Expandable Spacer SystemOrthofix US, LLC20224—
+6K203714NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System…Nu Vasive, Incorporated202166—
+6K212266FIX-C PEEK Anterior Cervical Interbody SystemJeil Medical Corporation20217—
+6K210573Velofix SA Cervical CageU&I Corporation20211—
+6K212562Idys-C ZP 3DTiClariance, SA20211—
+6K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210—
+6K201793EDEN Peek CageJmt Co., Ltd.20210—
+6K211413BEE PLIF CageNGMedical GmbH20211—
+6K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+6K210800IO Expandable Lumbar Interbody Fusion SystemMiRus, LLC20212—
+6K211388Lateral Spine Truss System (LSTS) Interbody Fusion Device4Web Medical, Inc.20210—
+6K210382Blustone Synergy Diamond SA Cervical SystemBlustone Synergy, LLC20210—
+6K210542aprevo Transforaminal IBFCarlsmed, Inc.202112—
+6K210595SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar SpacersCamber Spine Technologies, LLC20213—
+6K210583SeaSpine WaveForm™ A Interbody SystemSeaSpine Orthopedics Corporation202114—
+6K211258Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA…Medtronic Sofamor Danek USA, Inc.202175—
+6K210214NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody SystemNu Vasive, Incorporated20213—
+6K210439NuVasive MOD-EX XLIF Interbody SystemNu Vasive, Incorporated20214—
+6K210061ProLift Lateral HELO FixatedLife Spine, Inc.20213—
+6K203444BEE HA CageNGMedical GmbH20211—
+6K210155Duo Expandable Interbody Fusion SystemSpineology, Inc.20210—
+6K202872Prase PEEK Anterior Cervical Interbody SpacerGbs Commonwealth Co., Ltd.20215—
+6K200429BEE CagesNGMedical GmbH202111—
+6K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+6K203201NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated202194—
+6K203207Omnia Medical TiBrid-SAOmnia Medical, LLC202012
+6K202637F3D Corpectomy SystemCorelink, LLC20201—
+6K201643ChoiceSpine Tiger Shark Cervical Spacer SystemChoice Spine, LLC20204—
+6K201287Impulse Interbody Fusion SystemDegen Medical20208—
+6K202034aprevo Intervertebral Body Fusion DeviceCarlsmed, Inc.202017—
+6K203076Mecta-C Stand Alone ExtensionMedacta International S.A.20200—
+6K200316UNiD IB3D ALIFMedicrea International SA20200—
+6K202949CONSTRUX Mini PEEK Spacer SystemOrthofix, Inc.20206—
+6K202065DOLOMITE Anterior Cervical Stabilization SystemAstura Medical, LLC20203—
+6K202305Zavation IBF SystemZavation Medical Products, LLC20209—
+6K201820NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated2020156—
+6K201073Seaspine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202017—
+6K200958MODULIF-A Anterior Lumbar Interbody Fusion SystemSpinal Stability, LLC20200—
+6K201500Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar SpacerLife Spine, Inc.20203—
+6K201087CORBEL SpacersGlobus Medical, Inc.202036—
+6K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+6K200685RIGEL 3DR Anterior Cervical Interbody Fusion SystemMiRus, LLC20200—
+6K200235KONG-TL VBR System, KONG-C VBR SystemIcotec AG20201—
+6K191906MiRus 3D Printed Lumbar Interbody Fusion Systems consisting of the Callisto 3D Printed…MiRus, LLC20206—
+6K200541Hive™ Stand-alone Anterior Lumbar Interbody SystemHd Lifesciences, LLC20201—
+6K200338ProLift Lateral FixatedLife Spine, Inc.20205—
+6K200613Tritanium® X TL Expandable Curved Posterior Lumbar CageStryker Corporation20205—