510(k) Report

Devices descending from K012184

85 later devices reach Blackstone Iii Anterior Cervical Plating System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K200523Biolign® Roto-Loc Cervical Plate SystemElite Surgical Supplies (Pty), Ltd.20200—
+1K142060Transom Anterior Cervical PlateNeurostructures, Inc.201419—
+1K140234Aspiron Acp SystemU&I Corp.20146—
+1K131200Aspiron Acp SystemU&I Corporation20137—
+1K050892Hallmarktm Anterior Cervical Plate SystemBlackstone Medical, Inc.2005522
+1K030595Blackstone Fusion Anterior Cervical Plating SystemBlackstone Medical, Inc.200366—
+1K022965Blackstone Classic Anterior Cervical PlateBlackstone Medical, Inc.200310—
+1K020620Blackstone Iii Degree Anterior Cervical Plating System (Plate Washer)Blackstone Medical, Inc.20021—
+1K020600Blackstone Iii Anterior Cervical Plating System (Plate Washer)Blackstone Medical, Inc.20020—
+2K231251FlexWing Anterior Cervical Plate SystemJeil Medical Corporation20242—
+2K2117123° Anterior Cervical Plating System, Reliant Anterior Cervical Plating System, Unity…Orthofix US, LLC20220—
+2K200927Transept Cervical Plate SystemNeurostructures, Inc.20200—
+2K190053SECULOK™ ACP SystemU&I Corporation20191—
+2K182055SECULOK™ ACP SystemU&I Corporation20182—
+2K173521SeaSpine Cabo ACP (Anterior Cervical Plate) SystemSeaSpine Orthopedics Corporation201815—
+2K172585Liberty Anterior Cervical PlateValorus Spine20170—
+2K171112Trifore (tm) Cervical Plating SystemNeurostructures, Inc.20171—
+2K162638CETRA Anterior Cervical Plate SystemOrthofix, Inc.20163—
+2K161524Tangis Anterior Cervical PlateNvision Biomedical Technologies, LLC20168—
+2K130825Azure Anterior Cervical Plate SystemOrthofix, Inc.201311
+2K121658Orthofix Acp (Anterior Cervical Plate System)Orthofix, Inc.20124—
+2K100614Hallmark Anterior Cervcial Plate System, Hallmark Five-Level Cervical PlatesBlackstone Medical, Inc.201051—
+2K040003Vertebron SCP Cervical Plate SystemVertebron, Inc.200412—
+3K252826ARIX Femur Nail SystemJeil Medical Corporation20250—
+3K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+3K240935ARENAL Anterior Cervical Plate SystemEffortmed, LLC20240—
+3K220147Aspiron S ACP SystemU&I Corporation20220—
+3K210424Quantum Anterior Cervical PlateNvision Biomedical Technologies, Inc.20214—
+3K212139Admiral ACP SystemSeaSpine Orthopedics Corporation20216—
+3K211903Shoreline Threaded TruProfile® PlateSeaSpine Orthopedics Corporation20217—
+3K202657Javelin Tailor's Bunion Fixation SystemNvision Biomedical Technologies, Inc.20201—
+3K202064Admiral ACP SystemSeaSpine Orthopedics Corporation202014—
+3K193494Origin™ Anterior Cervical Plate SystemOrthopaedic & Spine Development20200—
+3K191786Cyclops™ Anterior Cervical Plate SystemDegen Medical, Inc.20191—
+3K181190Pinehurst Anterior Cervical Plate SystemSignature Orthopaedics Pty, Ltd.20190—
+3K173091Boundary Anterior Lumbar Buttress PlateNvision Biomedical Technologies, LLC20170—
+3K163104Terrace™ Anterior Cervical Plate SystemCorelink, LLC201718—
+3K163061Altus Spine Cervical Plate SystemAltus Partners, LLC20171—
+3K143028Azure Anterior Cervical Plate SystemOrthofix, Inc.20150—
+3K122216Reliance Anterior Cervical Plate SystemReliance Medical Systems, LLC20123—
+3K091396Cardo Medical Anterior Cervical Plate SystemCardo Medical Corp.20092—
+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—
+4K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+4K260291Vortex5 Tailor's Bunion Correction SystemNvision Biomedical Technologies, Inc.20260—
+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—
+4K232605Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue®…Lesspine Innovations20230—
+4K221572VyPlate Anterior Cervical Plate SystemVy Spine, LLC20221—
+4K213901Cyclops™ Anterior Cervical Plate SystemDegen Medical20220—
+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—
+4K140742Reliance Anterior Cervical PlateReliance Medical Systems, LLC20142—
+4K132310ASCOTBackroads Consulting, Inc.20130—
+4K062110Vertebron SCP Cervical Plate SystemVertebron, Inc.20069—
+5K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+5K260570corra™ cervical plating systemCarlsmed, Inc.20261—
+5K260697VyPlate™ Anterior Cervical Plate SystemVy Spine, LLC20260—
+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—
+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—
+6K262149corra® cervical plating systemCarlsmed, Inc.20260—
+6K253201Lumbar Spine Truss System - Plating Solution (LSTS-PS)4Web, Inc.20260—
+6K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc.20250—
+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—
+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—