510(k) Report

Devices descending from K990005

313 later devices reach Spinal Concepts, Inc. (Sci) Anterior Cervical Plate System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K240201PathLoc SI Joint Fusion SystemL&K BIOMED Co., Ltd.20240—
+5K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+5K232318VICTORY™ Lumbar Plate SystemGlobus Medical, Inc.20230—
+5K232605Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue®…Lesspine Innovations20230—
+5K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+5K231145Axis Anterior Cervical Plate SystemSouthern Medical (Pty), Ltd.20230—
+5K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+5K221572VyPlate Anterior Cervical Plate SystemVy Spine, LLC20221—
+5K220147Aspiron S ACP SystemU&I Corporation20220—
+5K213115CHENA-C Spacer SystemKahtnu Surgical, Inc.20210—
+5K210424Quantum Anterior Cervical PlateNvision Biomedical Technologies, Inc.20214—
+5K212139Admiral ACP SystemSeaSpine Orthopedics Corporation20216—
+5K211903Shoreline Threaded TruProfile® PlateSeaSpine Orthopedics Corporation20217—
+5K211408CervAlign® Anterior Cervical Plate SystemPioneer Surgical Technology, Inc.20211—
+5K202657Javelin Tailor's Bunion Fixation SystemNvision Biomedical Technologies, Inc.20201—
+5K202064Admiral ACP SystemSeaSpine Orthopedics Corporation202014—
+5K193494Origin™ Anterior Cervical Plate SystemOrthopaedic & Spine Development20200—
+5K191786Cyclops™ Anterior Cervical Plate SystemDegen Medical, Inc.20191—
+5K190016Lateral Plate SystemCorelink, LLC201915—
+5K183084Fuji Cervical Plate SystemAltus Partners, LLC20190—
+5K183409Athena II Cervical Plate SystemMedyssey USA, Inc.20191—
+5K181435ATEC Cervical Spacer SystemAlphatec Spine, Inc.2018100—
+5K180022Athena Cervical Plate SystemMedyssey USA, Inc.20182—
+5K173115COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and…Globus Medical, Inc.201783—
+5K173091Boundary Anterior Lumbar Buttress PlateNvision Biomedical Technologies, LLC20170—
+5K170961NuVasive CoRoent Small Interlock II SystemNu Vasive, Incorporated201718—
+5K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+5K143028Azure Anterior Cervical Plate SystemOrthofix, Inc.20150—
+5K133245Genesys Spine Anterior Cervical Plate II SystemGenesys Spine201411
+5K140742Reliance Anterior Cervical PlateReliance Medical Systems, LLC20142—
+5K062110Vertebron SCP Cervical Plate SystemVertebron, Inc.20069—
+6K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+6K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+6K260570corra™ cervical plating systemCarlsmed, Inc.20261—
+6K260697VyPlate™ Anterior Cervical Plate SystemVy Spine, LLC20260—
+6K260291Vortex5 Tailor's Bunion Correction SystemNvision Biomedical Technologies, Inc.20260—
+6K254182AsterOsteonic Co., Ltd.20260—
+6K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+6K251436Resolve Anterior Cervical Plate SystemPioneer Surgical Technology, Inc.20250—
+6K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+6K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+6K242069Eminent Spine Scoliosis Deformity Pedicle Screw SystemEminent Spine20240—
+6K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+6K231735NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody…Nu Vasive, Incorporated20239—
+6K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+6K230301Athena III Cervical Plate SystemMedyssey USA, Inc.20230—
+6K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+6K213901Cyclops™ Anterior Cervical Plate SystemDegen Medical20220—
+6K211805IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec…Alphatec Spine, Inc.202138—
+6K210382Blustone Synergy Diamond SA Cervical SystemBlustone Synergy, LLC20210—
+6K203065Lumbar Spine Truss System Plating Solution (LSTS-PS)4Web, Inc.20219—
+6K203076Mecta-C Stand Alone ExtensionMedacta International S.A.20200—
+6K202065DOLOMITE Anterior Cervical Stabilization SystemAstura Medical, LLC20203—
+6K201073Seaspine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202017—
+6K202192STRUXXURE®-L and STRUXXURE®-A Plate SystemNexxt Spine, LLC20200—
+6K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC202025—
+6K191477AEON-C Stand Alone SystemHuvexel Co., Ltd.201910—
+6K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+6K191243HEDRON Cervical SpacersGlobus Medical, Inc.201936—
+6K192076Binary® Anterior Cervical Plate SystemGenesys Spine20190—
+6K190885Elevation Spine Saber-C SystemElevation Spine201925—
+6K183705IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc.201999—
+6K180909REVEL SpacersGlobus Medical, Inc.201837—
+6K181621Stable-C Interbody SystemNexus Spine, LLC20187—
+7K262149corra® cervical plating systemCarlsmed, Inc.20260—
+7K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+7K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—
+7K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+7K260660SABER-C SystemElevation Spine20261—
+7K253260ORIO-3D Cage SystemSpineCraft20260—
+7K252432Flex-Z™ Cervical CageSpinepoint, LLC20260—
+7K253201Lumbar Spine Truss System - Plating Solution (LSTS-PS)4Web, Inc.20260—
+7K260038E3D™-C Interbody SystemEvolution Spine20261—
+7K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc.20250—
+7K250764SpineLinc Anterior Cervical Implant SystemLincotek Medical20250—
+7K250769Dakota LP SystemPrecision Spine, Inc.20250—
+7K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+7K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting20250—
+7K250540SABER-C SystemElevation Spine20252—
+7K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+7K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+7K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+7K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+7K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc.20241—
+7K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+7K241846E3D™-C Interbody SystemEvolution Spine20246—
+7K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody…Orthofix Medical, Inc.20242—
+7K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+7K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+7K230639Align Cervical Interbody Fusion SystemAcuity Surgical Devices, LLC20232—
+7K232348RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion SystemMiRus, LLC20231—
+7K231739Cervical Spine Truss System (CSTS)4Web Medical, Inc.20232—
+7K231147Hammerdesis™ Interphalangeal Fusion SystemIntelivation20230—
+7K231763Stable-C Interbody SystemNexus Spine, LLC20236—
+7K230329F3D Interbody SystemCorelink, LLC20230—
+7K223362Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device4Web Medical, Inc.20233—
+7K223140AEON-C™ Stand Alone SystemDio Medical, Inc.20222—
+7K223190Hive™ Standalone Cervical SystemNanoHive Medical, LLC20225—
+7K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—
+7K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—