510(k) Report

Devices descending from K041556

1,002 later devices reach Modification to Verte-Stack Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K113593Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC)2012102—
+6K113346Neon SystemUlrich GmbH & Co. KG20121—
+6K111076Solanas Avalon Posterior Fixation SystemAlphatec Spine, Inc.20115—
+7K263049SABER-C SystemElevation Spine20260—
+7K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+7K261049Scala® TLSpineart SA20260—
+7K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+7K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+7K253151Fule Interbody Fusion Cage SystemBeijing Fule Science & Technology Development Co., Ltd.20260—
+7K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+7K260837VersaLift Expandable SystemLife Spine, Inc.20260—
+7K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+7K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+7K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+7K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+7K260340HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC…HC Biologics, LLC20260—
+7K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine20260—
+7K253559Ventana™ A Anterior Lumbar Interbody SystemSpinal Elements, Inc.20260—
+7K253583LUX Expandable Lumbar Interbody SystemXenix Medical20260—
+7K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+7K250773Luna® Ti Interbody Fusion SystemSpinal Elements, Inc.20260—
+7K252219Cervical Interbody and VBR Fusion SystemSync Surgical20260—
+7K252686EffortMed PEEK Cages & Corpectomy CagesEffortmed, LLC20251—
+7K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+7K252742Navigated InstrumentsTyber Medical, LLC20251—
+7K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+7K253331PressON Spinal Fixation SystemNexus Spine20250—
+7K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+7K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+7K251459OneLIF™ Interbody Fusion SystemNovapproach Spine, LLC20250—
+7K250186GoLIF! Lumbar Interbody Fusion SystemGetset Surgical, SA20250—
+7K250605EVOL® ha – Hyper C Cervical Interbody Fusion SystemCutting Edge Spine, LLC20250—
+7K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+7K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+7K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+7K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+7K241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc.20241—
+7K242734ZSFab Cervical Interbody System; ZSFab Lumbar Interbody SystemZsfab20243—
+7K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+7K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc.20241—
+7K233947KLIMT™ Expandable Lumbar Interbody Fusion (LIF) Cage SystemCtl Medical Corporation20240—
+7K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+7K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc.20241—
+7K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+7K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+7K241846E3D™-C Interbody SystemEvolution Spine20246—
+7K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+7K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+7K240368E3D™-A Interbody SystemEvolution Spine20247—
+7K234119UniSpace® Stand-Alone C CageInnosys Co., Ltd.20241—
+7K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+7K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AG20240—
+7K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+7K240715Idys® C ZP 3DTiClariance20240—
+7K233359DOMINION Expandable Corpectomy SystemAstura Medical20242—
+7K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+7K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+7K233414Shoreline ACS Interbody System; Shoreline RT Interbody SystemSeaSpine Orthopedics Corporation20238—
+7K233078Posterior Cervical Spine SystemDouble Medical Technology, Inc.20231—
+7K233191TotalTi ACDF by SAGICOSpinal Analytics & Geometrical Implant Co, LLC20230—
+7K233366SYMPHONY OCT SystemMedos International SARL20230—
+7K232348RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion SystemMiRus, LLC20231—
+7K231704Pro-Link® & Pro-Link® Ti Barbs Cervical Spacer SystemLife Spine, Inc.20230—
+7K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+7K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+7K221138Titus Titanium Cervical by SAGICOSagico VA USA, LLC20231—
+7K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+7K231808QUASAR Standalone ACIF SystemGS Medical Co., Ltd.20230—
+7K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+7K231735NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody…Nu Vasive, Incorporated20239—
+7K221307Edge Upper Cervical SystemSpinal Simplicity, LLC20230—
+7K222015Integral Titanium Cervical InterbodyNvision Biomedical Technologies, Inc.20231—
+7K231252Ventana™ L Spinal SystemSpinal Elements, Inc.20231—
+7K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+7K230329F3D Interbody SystemCorelink, LLC20230—
+7K230614Cortium™Ulrich Medical USA20230—
+7K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+7K230026SqualeImplanet, S.A.20230—
+7K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+7K230583Tryptik TiSpineart SA20231—
+7K223688CONDUIT™ Lateral Lumbar Intervertebral Fusion Cage, CONDUIT™ InstrumentsMedos International Sàrl20230—
+7K223231Ti-Largo Cervical Interbody SystemFlospine20230—
+7K220296Manta Ray TDF SpacerSeaSpine Orthopedics Corporation20231—
+7K223105Tesera-K SC SystemKyocera Medical Technologies, Inc.20225—
+7K222806Kodiak C Spinal Implant SystemMet One Technologies, LLC20221—
+7K223140AEON-C™ Stand Alone SystemDio Medical, Inc.20222—
+7K2136534CIS Black Marlin Plif Cage System, 4CIS Dolphin Tlif Cage SystemSolco Biomedical Company India Private Limited20220—
+7K221578Hexanium ACIFSpinevision, S.A.S.20224—
+7K221162UniVy OsteoVy Cervical IBF SystemVy Spine, LLC20222—
+7K221858ZSFab Lumbar Interbody SystemZsfab, Inc.20224—
+7K221172FOCUS Interbody SystemOc Medical Devices20220—
+7K222383Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX Stealth (TM)…Medtronic Sofamor Danek USA, Inc.20220—
+7K220478NuVasive MOD-EX XLIF Interbody System, NuVasive MOD-EX XLIF Plated 2.0 Interbody SystemNu Vasive, Incorporated20222—
+7K220523restor3d TiDAL Lumbar Interbody Fusion DeviceRestor3D20222—
+7K220581Zavation eZspand Interbody SystemZavation Medical Products, LLC20224—
+7K220711SeaSpine Meridian System, SeaSpine Meridian Anterior Plate SystemSeaSpine Orthopedics Corporation202210—
+7K202266Reliance Cervical IBF SystemReliance Medical Systems, LLC20223—
+7K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20227—
+7K212904SeaSpine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202115—
+7K213359SeaSpine WaveForm, C Interbody SystemSeaSpine Orthopedics Corporation20217—