510(k) Report

Devices descending from K970462

72 later devices reach Acromed Anterior Cervical Stabilization System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K982443Doc Ventral Cervical Stabilization SystemDepuy Motech Acromed199871—
+2K190227Boomerang™ Anterior Cervical Plate SystemChoicespine, LP20194—
+2K121514Anodyne Anterior Cervical Plate SystemCorelink, LLC201221—
+2K112809Blue Mountain Cervical PlateQualgenix, LLC20122—
+2K073500Active Anterior Cervical Plate SystemSanacor20080—
+2K071990Valeo Cervical Plate SystemAmedica Corp.20071—
+2K051815Modification to Vertebron SCP Cervical Plate SystemVertebron, Inc.200510—
+2K043066Pioneer Anterior Cervical Plate SystemPioneer Surgical Technology200527—
+3K243369Cervical Plating SystemLife Spine, Inc.20240—
+3K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+3K163104Terrace™ Anterior Cervical Plate SystemCorelink, LLC201718—
+3K150036Blue Mountain Cervical Plate SystemSpineway20151—
+3K132310ASCOTBackroads Consulting, Inc.20130—
+3K132994Anodyne Anterior Cervical Plate SystemCorelink, LLC20131—
+3K100708Pioneer Anterior Cervical Plate Model 24-SeriesPioneer Surgical Technology201012—
+3K083663PACPPioneer Surgical Technology200917—
+3K082037Seeplate Cervical Plate SystemAmedica Corp.20080—
+3K081567Vertebron SSP Cervical Plating SystemVertebron, Inc.20086—
+3K073530Accin Anterior Cervical Plate SystemAccelerated Innovation, LLC20083—
+3K062110Vertebron SCP Cervical Plate SystemVertebron, Inc.20069—
+3K053053Pacp SystemPioneer Surgical Technology200525—
+4K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+4K232605Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue®…Lesspine Innovations20230—
+4K231145Axis Anterior Cervical Plate SystemSouthern Medical (Pty), Ltd.20230—
+4K193494Origin™ Anterior Cervical Plate SystemOrthopaedic & Spine Development20200—
+4K190016Lateral Plate SystemCorelink, LLC201915—
+4K183409Athena II Cervical Plate SystemMedyssey USA, Inc.20191—
+4K183060CervAlign™ Anterior Cervical Plate SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)201921
+4K180022Athena Cervical Plate SystemMedyssey USA, Inc.20182—
+4K163602Kepler I Cervical Plate SystemOrbbo Surgical, LLC20170—
+4K163061Altus Spine Cervical Plate SystemAltus Partners, LLC20171—
+4K130427Pioneer Aspect Anterior Cervical Plate SystemPioneer Surgical Technology, Inc.20135—
+4K122216Reliance Anterior Cervical Plate SystemReliance Medical Systems, LLC20123—
+4K111528Pioneer Aspect Anterior Cervical Plate Model 24-SeriesPioneer Surgical Technology, Inc.201111—
+4K091396Cardo Medical Anterior Cervical Plate SystemCardo Medical Corp.20092—
+4K072703Pioneer Slimfuse Anterior Cervical Plating SystemPioneer Surgical Technology200819—
+5K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—
+5K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+5K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+5K230301Athena III Cervical Plate SystemMedyssey USA, Inc.20230—
+5K221572VyPlate Anterior Cervical Plate SystemVy Spine, LLC20221—
+5K211408CervAlign® Anterior Cervical Plate SystemPioneer Surgical Technology, Inc.20211—
+5K203065Lumbar Spine Truss System Plating Solution (LSTS-PS)4Web, Inc.20219—
+5K202192STRUXXURE®-L and STRUXXURE®-A Plate SystemNexxt Spine, LLC20200—
+5K183084Fuji Cervical Plate SystemAltus Partners, LLC20190—
+5K133245Genesys Spine Anterior Cervical Plate II SystemGenesys Spine201411
+5K140742Reliance Anterior Cervical PlateReliance Medical Systems, LLC20142—
+5K121658Orthofix Acp (Anterior Cervical Plate System)Orthofix, Inc.20124—
+6K260697VyPlate™ Anterior Cervical Plate SystemVy Spine, LLC20260—
+6K253201Lumbar Spine Truss System - Plating Solution (LSTS-PS)4Web, Inc.20260—
+6K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc.20250—
+6K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+6K251436Resolve Anterior Cervical Plate SystemPioneer Surgical Technology, Inc.20250—
+6K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+6K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc.20241—
+6K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+6K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+6K231739Cervical Spine Truss System (CSTS)4Web Medical, Inc.20232—
+6K223362Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device4Web Medical, Inc.20233—
+6K212527Cervical Spine Truss System Plating Solution (CSTS-PS)4Web Medical, Inc.20220—
+6K191786Cyclops™ Anterior Cervical Plate SystemDegen Medical, Inc.20191—
+6K192076Binary® Anterior Cervical Plate SystemGenesys Spine20190—
+6K130825Azure Anterior Cervical Plate SystemOrthofix, Inc.201311
+7K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+7K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+7K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+7K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+7K251117Cervical Spine Truss System (CSTS)4Web Medical20250—
+7K233966Anterior Spine Truss System-Stand Alone (ASTS-SA)4Web Medical, Inc.20241—
+7K213901Cyclops™ Anterior Cervical Plate SystemDegen Medical20220—
+7K143028Azure Anterior Cervical Plate SystemOrthofix, Inc.20150—
+8K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—