510(k) Report

Devices descending from K050892

52 later devices reach Hallmarktm Anterior Cervical Plate System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K142060Transom Anterior Cervical PlateNeurostructures, Inc.201419—
+1K130825Azure Anterior Cervical Plate SystemOrthofix, Inc.201311
+1K121658Orthofix Acp (Anterior Cervical Plate System)Orthofix, Inc.20124—
+1K100614Hallmark Anterior Cervcial Plate System, Hallmark Five-Level Cervical PlatesBlackstone Medical, Inc.201051—
+2K2117123° Anterior Cervical Plating System, Reliant Anterior Cervical Plating System, Unity…Orthofix US, LLC20220—
+2K200927Transept Cervical Plate SystemNeurostructures, Inc.20200—
+2K191786Cyclops™ Anterior Cervical Plate SystemDegen Medical, Inc.20191—
+2K173521SeaSpine Cabo ACP (Anterior Cervical Plate) SystemSeaSpine Orthopedics Corporation201815—
+2K163104Terrace™ Anterior Cervical Plate SystemCorelink, LLC201718—
+2K171112Trifore (tm) Cervical Plating SystemNeurostructures, Inc.20171—
+2K162638CETRA Anterior Cervical Plate SystemOrthofix, Inc.20163—
+2K143028Azure Anterior Cervical Plate SystemOrthofix, Inc.20150—
+2K122216Reliance Anterior Cervical Plate SystemReliance Medical Systems, LLC20123—
+3K240935ARENAL Anterior Cervical Plate SystemEffortmed, LLC20240—
+3K232605Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue®…Lesspine Innovations20230—
+3K221572VyPlate Anterior Cervical Plate SystemVy Spine, LLC20221—
+3K213901Cyclops™ Anterior Cervical Plate SystemDegen Medical20220—
+3K212139Admiral ACP SystemSeaSpine Orthopedics Corporation20216—
+3K211903Shoreline Threaded TruProfile® PlateSeaSpine Orthopedics Corporation20217—
+3K202064Admiral ACP SystemSeaSpine Orthopedics Corporation202014—
+3K193494Origin™ Anterior Cervical Plate SystemOrthopaedic & Spine Development20200—
+3K190016Lateral Plate SystemCorelink, LLC201915—
+3K181190Pinehurst Anterior Cervical Plate SystemSignature Orthopaedics Pty, Ltd.20190—
+3K140742Reliance Anterior Cervical PlateReliance Medical Systems, LLC20142—
+4K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+4K260697VyPlate™ Anterior Cervical Plate SystemVy Spine, LLC20260—
+4K254182AsterOsteonic Co., Ltd.20260—
+4K252611aprevo® cervical plating systemCarlsmed, Inc.20253—
+4K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+4K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+4K203065Lumbar Spine Truss System Plating Solution (LSTS-PS)4Web, Inc.20219—
+4K202192STRUXXURE®-L and STRUXXURE®-A Plate SystemNexxt Spine, LLC20200—
+5K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+5K260570corra™ cervical plating systemCarlsmed, Inc.20261—
+5K253201Lumbar Spine Truss System - Plating Solution (LSTS-PS)4Web, Inc.20260—
+5K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc.20250—
+5K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+5K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+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—
+6K262149corra® cervical plating systemCarlsmed, Inc.20260—
+6K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+6K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+6K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+6K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+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—