510(k) Report

Devices descending from K102820

38 later devices reach Appliance, Fixation, Spinal Intervertebral Body through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K200995Insignia™ Anterior Cervical Plate SystemAlphatec Spine, Inc.2020729
+1K163104Terrace™ Anterior Cervical Plate SystemCorelink, LLC201718—
+1K152193Renovis Anterior Cervical Plate SystemRenovis Surgical Technologies, Inc.20154—
+1K111132Genesys Spine Anterior Cervical Plate SystemGenesys Spine201141
+1K103137Venus Anterior Cervical PlateVerticor, Ltd.20115—
+2K232605Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue®…Lesspine Innovations20230—
+2K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+2K213443Insignia™ Anterior Cervical Plate SystemAlphatec Spine, Inc.20216—
+2K193494Origin™ Anterior Cervical Plate SystemOrthopaedic & Spine Development20200—
+2K190016Lateral Plate SystemCorelink, LLC201915—
+2K133245Genesys Spine Anterior Cervical Plate II SystemGenesys Spine201411
+2K131512Katia SystemShanghai Sanyou Medical Co, Ltd.20131—
+3K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+3K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+3K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+3K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+3K203065Lumbar Spine Truss System Plating Solution (LSTS-PS)4Web, Inc.20219—
+3K202192STRUXXURE®-L and STRUXXURE®-A Plate SystemNexxt Spine, LLC20200—
+3K192076Binary® Anterior Cervical Plate SystemGenesys Spine20190—
+3K163366Shanghai Sanyou CARMEN Cervical Fusion SystemShanghai Sanyou Medical Co, Ltd.20170—
+4K253201Lumbar Spine Truss System - Plating Solution (LSTS-PS)4Web, Inc.20260—
+4K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc.20250—
+4K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+4K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+4K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc.20241—
+4K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+4K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+4K231739Cervical Spine Truss System (CSTS)4Web Medical, Inc.20232—
+4K223362Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device4Web Medical, Inc.20233—
+4K212527Cervical Spine Truss System Plating Solution (CSTS-PS)4Web Medical, Inc.20220—
+5K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+5K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—
+5K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+5K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+5K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+5K251117Cervical Spine Truss System (CSTS)4Web Medical20250—
+5K233966Anterior Spine Truss System-Stand Alone (ASTS-SA)4Web Medical, Inc.20241—
+6K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—