510(k) Report

Devices descending from K030736

1,101 later devices reach Verte-Stack Spinal System, Extra Small Sizes through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K122591Clydesdale Spinal SystemMedtronic Sofamor Danek, Inc.201214—
+4K121096Venus Lumbar Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd.201236—
+4K120063Venus Lumbar Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd.201237—
+4K112459Synthes Zero-PSynthes Spine Co.Lp2011277—
+4K112068Synthes Zero-P Variable Angle (VA)Synthes Spine Co.Lp2011331
+4K102315Staxx XDL SystemSpine Wave, Inc.20113—
+4K111469Staxxsd SystemSpine Wave, Inc.20110—
+4K110522Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc.2011106—
+4K102323Cervical Standalone Intervertebral Body Fusion DeviceTheken Spine, LLC201062—
+4K094042Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek2010397—
+4K093434Vertex Reconstruction System and Vertex Select Reconstruction SystemMedtronic Sofamor Danek20097—
+4K090315Staxx XD SystemSpine Wave, Inc.20096—
+4K080860Creaspine Supstance Small Vertebral Body Replacement SystemCreaspine20080—
+4K073420Blackstone Ascent Multiaxial ScrewsBlackstone Medical, Inc.20089—
+5K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+5K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+5K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+5K260810Anteralign LS coverplateTyber Medical, LLC20260—
+5K253195TAURUS Posterior Occipital-Cervico-Thoracic Spinal SystemsZheJiang Decans Medical Devices Co., Ltd.20260—
+5K253213SAGI Cervical Cage SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+5K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+5K254017SWINGO-3D Lumbar Cage SystemImplanet20260—
+5K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+5K254165Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20260—
+5K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+5K253577IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)Medicrea International S.A.S. (Medtronic)20250—
+5K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc.20250—
+5K250764SpineLinc Anterior Cervical Implant SystemLincotek Medical20250—
+5K252610ZSFab Lumbar Interbody SystemZsfab, Inc.20251—
+5K250769Dakota LP SystemPrecision Spine, Inc.20250—
+5K250560BEE HANGMedical GmbH20250—
+5K252351UniSpace® TPLIF CageCg Medtech Co., Ltd.20250—
+5K252742Navigated InstrumentsTyber Medical, LLC20251—
+5K253129Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20250—
+5K251725ANAX™ OCT Spinal SystemCg Medtech Co., Ltd.20250—
+5K251459OneLIF™ Interbody Fusion SystemNovapproach Spine, LLC20250—
+5K251117Cervical Spine Truss System (CSTS)4Web Medical20250—
+5K250669Adaptix™ Interbody System with Titan nanoLOCK™ Surface TechnologyMedtronic Sofamor Danek USA, Inc.20250—
+5K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—
+5K250605EVOL® ha – Hyper C Cervical Interbody Fusion SystemCutting Edge Spine, LLC20250—
+5K243915FIX-C 3D Ti ACIF SystemJeil Medical Corporation20250—
+5K242589Scarlet® AL-TSpineart SA20240—
+5K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc.20241—
+5K241321Juliet® Ti LL Lumbar Interbody DeviceSpineart SA20240—
+5K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical20244—
+5K240699SCARLET® AC-TiSpineart SA20240—
+5K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AG20240—
+5K240715Idys® C ZP 3DTiClariance20240—
+5K233375Tranquil-L Interbody SystemNexus Spine, LLC20240—
+5K230872Halis™ Lumbar Cage System, Lydia™ Anterior Lumbar Fusion System, Dica™ Direction…Shanghai Sanyou Medical Co, Ltd.20231—
+5K232345ATEC Posterior Navigated Disc Prep InstrumentsAlphatec Spine, Inc.20232—
+5K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+5K232481RIGEL™ 3DR Anterior Cervical Corpectomy SystemMiRus, LLC20230—
+5K222988neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D CervicalHt Medical D.B.A. Xenix Medical20232—
+5K230607SPICCA Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+5K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+5K230329F3D Interbody SystemCorelink, LLC20230—
+5K220261NEST-C Interbody SystemPaonan Biotech Co., Ltd.20230—
+5K230026SqualeImplanet, S.A.20230—
+5K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+5K230583Tryptik TiSpineart SA20231—
+5K223494CD Horizon Spinal SystemMedtronic202317—
+5K223764INFINITY OCT SystemMedtronic Sofamor Danek USA, Inc.20230—
+5K221182Southern Transforaminal Lumbar Interbody Fusion (TLIF)Southern Medical (Pty), Ltd.20220—
+5K222903Tailored-H Cervical Stand Alone SystemBespoke Technologies, LLC20220—
+5K220334MONET Anterior Cervical Plate SystemCtl Medical Corporation20220—
+5K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+5K221646CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™…Medtronic Sofamor Danek USA, Inc.202220—
+5K213417Ghost Spacer SystemLife Spine, Inc.20220—
+5K220953ChoiceSpine TigerShark™ M, Modular Interbody SystemChoice Spine, LLC20220—
+5K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+5K220523restor3d TiDAL Lumbar Interbody Fusion DeviceRestor3D20222—
+5K212450Keos Anterior Cervical Interbody Fusion Device SystemKeos20220—
+5K221180Anteralign (TM) Spinal System with Titan NanoLOCK Surface Technology Navigated InstrumentsMedtronic Sofamor Danek USA, Inc.20222—
+5K220810Infinity™ OCT System and PASS OCT Spinal SystemMedicrea International20220—
+5K213441PathLoc Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20222—
+5K220096Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20220—
+5K214011Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™ TL Spinal…Medtronic Sofamor Danek USA, Inc.20221—
+5K212075ShurFit Lumbar Interbody SystemPrecision Spine, Inc.20211—
+5K213115CHENA-C Spacer SystemKahtnu Surgical, Inc.20210—
+5K212653Catalyft LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.202127
+5K212389Advantage Lumbar System - ALIF, PLIF, DLIF, TLIFIntelivation, LLC20210—
+5K212070KMTI S141 Lumbar Interbody Fusion SystemKyocera Medical Technologies, Inc.20210—
+5K210090Impulse AM Interbody Fusion SystemDegen Medical20217—
+5K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+5K210521DEXA-C Cervical Interbody SystemAurora Spine, Inc.20210—
+5K210044Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System…Spinal Elements, Inc.20211—
+5K211441Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.20219—
+5K201671A-Link ZAcuity Surgical Devices, LLC202125—
+5K200919Idys ALIF 3DTiClariance20210—
+5K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+5K202032Idys LLIF 3DTiClariance, Sas20210—
+5K203038Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20215—
+5K210449Infinity™ OCT System, PASS OCT® Spinal SystemMedtronic20213—
+5K203444BEE HA CageNGMedical GmbH20211—
+5K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc.202135—
+5K203683CarboClear Lumbar Cage SystemCarbofix Orthpedics, Ltd.20211—
+5K202495SIRION Lateral Lumbar Interbody FusionAstura Medical, LLC20216—
+5K202820Australis Anterior Lumbar Cage SystemPrism Surgical Designs Pty, Ltd.20200—
+5K200719NuVasive Navigation.S InstrumentsNu Vasive, Incorporated20204—