510(k) Report

Devices descending from K970048

54 later devices reach Synthes (Usa)Titanium Locking Plate System (Tilps) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K170530Butrex Lumbar Buttress Plating SystemX-Spine Systems, Inc.20170—
+1K081418Spinal Elements Buttress Plate SystemSpinal Elements, Inc.20080—
+1K073349Reliance Buttress Washer SystemReliance Medical Systems, LLC20081—
+1K040130Anterior Lumbar Buttress SystemSeaspine20044—
+1K012881C3 Anterior Cervical Plate SystemSpine Vision, Inc.20014—
+1K010466Tether AcfsTheken Surgical,Llc200143—
+1K994383Dogbone AcfsTheken Surgical20000—
+2K213219Vy Spine™ VyWasher™ Buttress SystemVy Spine, LLC20210—
+2K170342Ocata Anterior Cervical SystemKalitec Direct, LLC20171—
+2K143065NuVasive ALIF Buttress Plate SystemNu Vasive, Incorporated20151—
+2K121514Anodyne Anterior Cervical Plate SystemCorelink, LLC201221—
+2K112809Blue Mountain Cervical PlateQualgenix, LLC20122—
+2K073500Active Anterior Cervical Plate SystemSanacor20080—
+2K080690Manta Ray Anterior Cervical Plate SystemTheken Spine, LLC200802
+2K071990Valeo Cervical Plate SystemAmedica Corp.20071—
+2K040003Vertebron SCP Cervical Plate SystemVertebron, Inc.200412—
+3K261309Palisades™ Buttress Plate SystemBethesda Medical Devices, LLC20260—
+3K172086Matira™ Anterior Cervical SystemKalitec Direct, LLC20170—
+3K163104Terrace™ Anterior Cervical Plate SystemCorelink, LLC201718—
+3K163061Altus Spine Cervical Plate SystemAltus Partners, LLC20171—
+3K150036Blue Mountain Cervical Plate SystemSpineway20151—
+3K132994Anodyne Anterior Cervical Plate SystemCorelink, LLC20131—
+3K091396Cardo Medical Anterior Cervical Plate SystemCardo Medical Corp.20092—
+3K082037Seeplate Cervical Plate SystemAmedica Corp.20080—
+3K081567Vertebron SSP Cervical Plating SystemVertebron, Inc.20086—
+3K073530Accin Anterior Cervical Plate SystemAccelerated Innovation, LLC20083—
+3K051815Modification to Vertebron SCP Cervical Plate SystemVertebron, Inc.200510—
+3K043181Modification to Vertebron SCP Cervical Plate SystemVertebron, Inc.200411—
+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—
+4K183084Fuji Cervical Plate SystemAltus Partners, LLC20190—
+4K183409Athena II Cervical Plate SystemMedyssey USA, Inc.20191—
+4K180022Athena Cervical Plate SystemMedyssey USA, Inc.20182—
+4K163602Kepler I Cervical Plate SystemOrbbo Surgical, LLC20170—
+4K132310ASCOTBackroads Consulting, Inc.20130—
+4K062110Vertebron SCP Cervical Plate SystemVertebron, Inc.20069—
+5K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+5K230301Athena III Cervical Plate SystemMedyssey USA, Inc.20230—
+5K203065Lumbar Spine Truss System Plating Solution (LSTS-PS)4Web, Inc.20219—
+5K202192STRUXXURE®-L and STRUXXURE®-A Plate SystemNexxt Spine, LLC20200—
+6K253201Lumbar Spine Truss System - Plating Solution (LSTS-PS)4Web, Inc.20260—
+6K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc.20250—
+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—
+7K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+7K251117Cervical Spine Truss System (CSTS)4Web Medical20250—
+7K233966Anterior Spine Truss System-Stand Alone (ASTS-SA)4Web Medical, Inc.20241—
+8K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—