510(k) Report

Devices descending from K030601

1,151 later devices reach Verte-Stack Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+8K253583LUX Expandable Lumbar Interbody SystemXenix Medical20260—
+8K253748Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer SystemLife Spine, Inc.20260—
+8K254165Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20260—
+8K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+8K253158VyBrate™ VBR SystemVy Spine, LLC20260—
+8K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+8K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc.20250—
+8K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+8K250560BEE HANGMedical GmbH20250—
+8K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+8K253129Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20250—
+8K253377Expandable Titanium PLIF/TLIF SystemSpectrum Spine, Inc.20250—
+8K250540SABER-C SystemElevation Spine20252—
+8K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+8K251725ANAX™ OCT Spinal SystemCg Medtech Co., Ltd.20250—
+8K251003X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+8K251335Tera Lumbar Interbody Fusion System (Various PNs)Acuity Surgical Devices, LLC20251—
+8K243116FlareHawk Interbody Fusion SystemIntegrity Implants Inc. Dba Accelus20250—
+8K250602X-PAC® N-GAGE™ Lumbar Plate SystemExpanding Innovations, Inc.20250—
+8K251117Cervical Spine Truss System (CSTS)4Web Medical20250—
+8K250373ProLift Expandable Spacer SystemLife Spine, Inc.20251—
+8K242483Genesys Spine AIS-C II Cervical Interbody Fusion SystemGenesys Spine20250—
+8K243668ProLift Pivot Expandable Spacer SystemLife Spine, Inc.20250—
+8K242826ProLift Wedge Expandable Spacer SystemLife Spine, Inc.20240—
+8K242509HAnano InterFuse (R) Modular InterbodyNext Orthosurgical20240—
+8K241413sagAlign Lumbar Cage System (Various PNs)Acuity Surgical Devices, LLC20240—
+8K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical20244—
+8K241396uCerv Flux™-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA, Inc.20240—
+8K240625CORUS Navigation Access SystemProvidence Medical Technology, Inc.20244—
+8K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+8K234150Lucent® XPSpinal Elements20240—
+8K240715Idys® C ZP 3DTiClariance20240—
+8K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+8K232611TruLift Micro Expandable Spacer System & TruLift Expandable Spacer SystemLife Spine, Inc.20232—
+8K233191TotalTi ACDF by SAGICOSpinal Analytics & Geometrical Implant Co, LLC20230—
+8K230478Acro Composites Interbody SystemAcro Composites, LLC20230—
+8K231486Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20231—
+8K232530Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemNexus Spine, LLC20235—
+8K231147Hammerdesis™ Interphalangeal Fusion SystemIntelivation20230—
+8K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+8K232150ZSFab Cervical Interbody SystemZsfab, Inc.20234—
+8K230607SPICCA Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+8K221138Titus Titanium Cervical by SAGICOSagico VA USA, LLC20231—
+8K231275Exceed™ Biplanar Expandable Interbody SystemSpine Wave, Inc.20232—
+8K223868PYXIS 3D Titanium Cage SystemGS Medical Co., Ltd.20232—
+8K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+8K222041CYGNUS-C Standalone ACIF SystemGS Medical Co., Ltd.20231—
+8K220296Manta Ray TDF SpacerSeaSpine Orthopedics Corporation20231—
+8K223731NuVasive Modulus-C Interbody SystemNuvasive, Inc.202311—
+8K223764INFINITY OCT SystemMedtronic Sofamor Danek USA, Inc.20230—
+8K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+8K223190Hive™ Standalone Cervical SystemNanoHive Medical, LLC20225—
+8K222903Tailored-H Cervical Stand Alone SystemBespoke Technologies, LLC20220—
+8K221751NuVasive Cohere ALIF System Intervertebral Body Fusion DeviceNu Vasive, Incorporated20223—
+8K221325CONDUIT Lateral Switch PlateMedos International SARL20221—
+8K220696uCerv Flux-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA20221—
+8K213791Unispace SA Cervical CageEdisoninno Co., Ltd.20222—
+8K212450Keos Anterior Cervical Interbody Fusion Device SystemKeos20220—
+8K211837Altus Spine Interbody Standalone Fusion SystemAltus Partners, LLC20220—
+8K220810Infinity™ OCT System and PASS OCT Spinal SystemMedicrea International20220—
+8K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC20223—
+8K213355Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20224—
+8K212358Romero Cervical CageSpineup, Inc.20226—
+8K203714NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System…Nu Vasive, Incorporated202166—
+8K213115CHENA-C Spacer SystemKahtnu Surgical, Inc.20210—
+8K210590Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20210—
+8K211805IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec…Alphatec Spine, Inc.202138—
+8K211903Shoreline Threaded TruProfile® PlateSeaSpine Orthopedics Corporation20217—
+8K210521DEXA-C Cervical Interbody SystemAurora Spine, Inc.20210—
+8K210574NuVasive Pulse SystemNu Vasive, Incorporated202121
+8K210382Blustone Synergy Diamond SA Cervical SystemBlustone Synergy, LLC20210—
+8K203311ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20213—
+8K210449Infinity™ OCT System, PASS OCT® Spinal SystemMedtronic20213—
+8K203444BEE HA CageNGMedical GmbH20211—
+8K203361ProLift Wedge Expandable Spacer SystemLife Spine, Inc.20211—
+8K210271NuVasive Modulus ALIF SystemNu Vasive, Incorporated20215—
+8K203327VERTACONNECT TLIF CageSignus Medizintechnik20210—
+8K203129NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) SystemPrecision Spine, Inc.20210—
+8K202488ZSFab Cervical Interbody SystemZsfab, Inc.20216—
+8K202298Lucent XP, Lucent XP CurvedSpinal Elements, Inc.20202—
+8K200549Lucero Medical Cervical Cage SystemLucero Medical, LLC20200—
+8K201755WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody SystemSeaSpine Orthopedics Corporation202017—
+8K201692NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated202067—
+8K202065DOLOMITE Anterior Cervical Stabilization SystemAstura Medical, LLC20203—
+8K193000Hexanium® ACIFSpinevision, S.A.S.202014—
+8K201453Fortilink Cages with TiPlus TechnologyParadigm Spine GmbH20204—
+8K200953NuVasive® Cohere® Thoracolumbar Interbody SystemNu Vasive, Incorporated2020141—
+8K201073Seaspine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202017—
+8K201721TruLift Expandable Spacer SystemLife Spine, Inc.20205—
+8K201769Cavetto [MAX] Cervical Cage SystemNeurostructures, Inc.20200—
+8K192863MONDRIAN Lumbar Interbody Fusion Cage SystemCtl Medical Corporation20203—
+8K201605EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF Cage, EIT Cellular…Eit Emerging Implant Technologies GmbH2020130—
+8K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC202025—
+8K200879SeaSpine Meridian System, SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation202060—
+8K200235KONG-TL VBR System, KONG-C VBR SystemIcotec AG20201—
+8K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+8K200352Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20202—
+8K191906MiRus 3D Printed Lumbar Interbody Fusion Systems consisting of the Callisto 3D Printed…MiRus, LLC20206—
+8K192646SYMPHONY™ OCT SystemMedos International SARL20202—