510(k) Report

Devices descending from K040536

1,150 later devices reach Modification to Verte-Stack Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K241396uCerv Flux™-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA, Inc.20240—
+7K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+7K232282aprevo® anterior and lateral lumbar interbody fusion device, aprevo® transforaminal…Carlsmed, Inc.20240—
+7K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+7K232432E3D™-A Interbody SystemEvolution Spine20248—
+7K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+7K233594Genesys Spine 3DP AIS-C II Cervical Interbody SystemGenesys Spine20232—
+7K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+7K230478Acro Composites Interbody SystemAcro Composites, LLC20230—
+7K231147Hammerdesis™ Interphalangeal Fusion SystemIntelivation20230—
+7K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+7K222988neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D CervicalHt Medical D.B.A. Xenix Medical20232—
+7K232150ZSFab Cervical Interbody SystemZsfab, Inc.20234—
+7K230607SPICCA Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+7K231241NanoHive Medical Lumbar Interbody SystemNanoHive Medical, LLC20230—
+7K231252Ventana™ L Spinal SystemSpinal Elements, Inc.20231—
+7K230731Zavation ALIF SystemZavation Medical Products, LLC20232—
+7K230851Kodiak Lumbar Spacer SystemMet One Technologies, LLC20230—
+7K231140aprevo® transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20236—
+7K223335SIRION Lateral Lumbar Interbody SystemAstura Medical20230—
+7K223430ProLift Micro Expandable Spacer SystemLife Spine, Inc.20236—
+7K221324ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF)Camber Spine Technologies20230—
+7K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+7K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+7K223418DeGen Impulse AM™ SystemDegen Medical20236—
+7K223688CONDUIT™ Lateral Lumbar Intervertebral Fusion Cage, CONDUIT™ InstrumentsMedos International Sàrl20230—
+7K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+7K223174X-Pac Expandable LLIF Cage SystemExpanding Innovations, Inc.20233—
+7K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+7K222041CYGNUS-C Standalone ACIF SystemGS Medical Co., Ltd.20231—
+7K223764INFINITY OCT SystemMedtronic Sofamor Danek USA, Inc.20230—
+7K2136534CIS Black Marlin Plif Cage System, 4CIS Dolphin Tlif Cage SystemSolco Biomedical Company India Private Limited20220—
+7K223190Hive™ Standalone Cervical SystemNanoHive Medical, LLC20225—
+7K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc.20221—
+7K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—
+7K222903Tailored-H Cervical Stand Alone SystemBespoke Technologies, LLC20220—
+7K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+7K223065Adcura® Sagittae® Lateral Lumbar Interbody Fusion DevicesAdcura, Inc.20220—
+7K222203DualXSLIM (R) T/PLIFAmplify Surgical, Inc.20223—
+7K222561AlignAcuity Surgical Devices, LLC202214—
+7K220696uCerv Flux-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA20221—
+7K213791Unispace SA Cervical CageEdisoninno Co., Ltd.20222—
+7K221535Align Lumbar Interbody Fusion SystemAcuity Surgical Devices, LLC20223—
+7K220478NuVasive MOD-EX XLIF Interbody System, NuVasive MOD-EX XLIF Plated 2.0 Interbody SystemNu Vasive, Incorporated20222—
+7K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+7K212450Keos Anterior Cervical Interbody Fusion Device SystemKeos20220—
+7K220610SOLO-LAurora Spine, Inc.20220—
+7K220810Infinity™ OCT System and PASS OCT Spinal SystemMedicrea International20220—
+7K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+7K213118Dakota ALIF SystemPrecision Spine, Inc.20220—
+7K220453FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20221—
+7K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20227—
+7K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+7K212358Romero Cervical CageSpineup, Inc.20226—
+7K212904SeaSpine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202115—
+7K213359SeaSpine WaveForm, C Interbody SystemSeaSpine Orthopedics Corporation20217—
+7K213115CHENA-C Spacer SystemKahtnu Surgical, Inc.20210—
+7K212562Idys-C ZP 3DTiClariance, SA20211—
+7K212520ProLift Micro Expandable Spacer SystemLife Spine, Inc.20216—
+7K211740DualXAmplify Surgical, Inc.20211—
+7K211903Shoreline Threaded TruProfile® PlateSeaSpine Orthopedics Corporation20217—
+7K211388Lateral Spine Truss System (LSTS) Interbody Fusion Device4Web Medical, Inc.20210—
+7K210521DEXA-C Cervical Interbody SystemAurora Spine, Inc.20210—
+7K210382Blustone Synergy Diamond SA Cervical SystemBlustone Synergy, LLC20210—
+7K203003Pantheon IBFDPantheon Spinal20210—
+7K210044Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System…Spinal Elements, Inc.20211—
+7K211441Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.20219—
+7K210439NuVasive MOD-EX XLIF Interbody SystemNu Vasive, Incorporated20214—
+7K210061ProLift Lateral HELO FixatedLife Spine, Inc.20213—
+7K201024Expandable Titanium PLIF/TLIF SystemSpectrum Spine, LLC20215—
+7K203038Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20215—
+7K210449Infinity™ OCT System, PASS OCT® Spinal SystemMedtronic20213—
+7K203444BEE HA CageNGMedical GmbH20211—
+7K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+7K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+7K203129NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) SystemPrecision Spine, Inc.20210—
+7K203201NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated202194—
+7K202488ZSFab Cervical Interbody SystemZsfab, Inc.20216—
+7K201643ChoiceSpine Tiger Shark Cervical Spacer SystemChoice Spine, LLC20204—
+7K200549Lucero Medical Cervical Cage SystemLucero Medical, LLC20200—
+7K200719NuVasive Navigation.S InstrumentsNu Vasive, Incorporated20204—
+7K202065DOLOMITE Anterior Cervical Stabilization SystemAstura Medical, LLC20203—
+7K193000Hexanium® ACIFSpinevision, S.A.S.202014—
+7K201820NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated2020156—
+7K201073Seaspine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202017—
+7K201769Cavetto [MAX] Cervical Cage SystemNeurostructures, Inc.20200—
+7K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC202025—
+7K200235KONG-TL VBR System, KONG-C VBR SystemIcotec AG20201—
+7K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+7K200816SpineEX Sagittae Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20201—
+7K200338ProLift Lateral FixatedLife Spine, Inc.20205—
+7K200613Tritanium® X TL Expandable Curved Posterior Lumbar CageStryker Corporation20205—
+7K192646SYMPHONY™ OCT SystemMedos International SARL20202—
+7K193593NuVasive 3DP Interfixated ALIF SystemNu Vasive, Incorporated2020157—
+7K193359SureMAX Family of Cervical SpacersAdditive Implants, Inc.202014—
+7K1920444CIS Marlin PEEK ACIF CageSolco Biomedical Co., Ltd.20190—
+7K192248Cortina™ [MAX] Lumbar Cage SystemNeurostructures, Inc.20190—
+7K191477AEON-C Stand Alone SystemHuvexel Co., Ltd.201910—
+7K190426ALTA Anterior Cervical Corpectomy SystemAstura Medical, LLC20193—
+7K191584FORTICO Anterior Cervical Fixation SystemCamber Spine Technologies, LLC20192—