510(k) Report

Devices descending from K010466

43 later devices reach Tether Acfs through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K170342Ocata Anterior Cervical SystemKalitec Direct, LLC20171—
+1K121514Anodyne Anterior Cervical Plate SystemCorelink, LLC201221—
+1K112809Blue Mountain Cervical PlateQualgenix, LLC20122—
+1K080690Manta Ray Anterior Cervical Plate SystemTheken Spine, LLC200802
+1K071990Valeo Cervical Plate SystemAmedica Corp.20071—
+1K040003Vertebron SCP Cervical Plate SystemVertebron, Inc.200412—
+2K172086Matira™ Anterior Cervical SystemKalitec Direct, LLC20170—
+2K163104Terrace™ Anterior Cervical Plate SystemCorelink, LLC201718—
+2K163061Altus Spine Cervical Plate SystemAltus Partners, LLC20171—
+2K150036Blue Mountain Cervical Plate SystemSpineway20151—
+2K132994Anodyne Anterior Cervical Plate SystemCorelink, LLC20131—
+2K091396Cardo Medical Anterior Cervical Plate SystemCardo Medical Corp.20092—
+2K082037Seeplate Cervical Plate SystemAmedica Corp.20080—
+2K081567Vertebron SSP Cervical Plating SystemVertebron, Inc.20086—
+2K073530Accin Anterior Cervical Plate SystemAccelerated Innovation, LLC20083—
+2K051815Modification to Vertebron SCP Cervical Plate SystemVertebron, Inc.200510—
+2K043181Modification to Vertebron SCP Cervical Plate SystemVertebron, Inc.200411—
+3K232605Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue®…Lesspine Innovations20230—
+3K231145Axis Anterior Cervical Plate SystemSouthern Medical (Pty), Ltd.20230—
+3K193494Origin™ Anterior Cervical Plate SystemOrthopaedic & Spine Development20200—
+3K190016Lateral Plate SystemCorelink, LLC201915—
+3K183084Fuji Cervical Plate SystemAltus Partners, LLC20190—
+3K183409Athena II Cervical Plate SystemMedyssey USA, Inc.20191—
+3K180022Athena Cervical Plate SystemMedyssey USA, Inc.20182—
+3K163602Kepler I Cervical Plate SystemOrbbo Surgical, LLC20170—
+3K132310ASCOTBackroads Consulting, Inc.20130—
+3K062110Vertebron SCP Cervical Plate SystemVertebron, Inc.20069—
+4K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+4K230301Athena III Cervical Plate SystemMedyssey USA, Inc.20230—
+4K203065Lumbar Spine Truss System Plating Solution (LSTS-PS)4Web, Inc.20219—
+4K202192STRUXXURE®-L and STRUXXURE®-A Plate SystemNexxt Spine, LLC20200—
+5K253201Lumbar Spine Truss System - Plating Solution (LSTS-PS)4Web, Inc.20260—
+5K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc.20250—
+5K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc.20241—
+5K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+5K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+5K231739Cervical Spine Truss System (CSTS)4Web Medical, Inc.20232—
+5K223362Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device4Web Medical, Inc.20233—
+5K212527Cervical Spine Truss System Plating Solution (CSTS-PS)4Web Medical, Inc.20220—
+6K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+6K251117Cervical Spine Truss System (CSTS)4Web Medical20250—
+6K233966Anterior Spine Truss System-Stand Alone (ASTS-SA)4Web Medical, Inc.20241—
+7K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—