510(k) Report

Devices descending from K040844

77 later devices reach Life Spine Neo Anterior Cervical Plate System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K110990Gso ACP1 Anterior Cervical Plate SystemGold Standard Orthopedics, LLC20110—
+1K070285Life Spine Anterior Cervical Plate SystemLife Spine200757—
+1K062643Kinetic Anterior Cervical PlateLife Spine200653—
+1K062831Modification to Life Spine Neo Anterior Cervical Plate SystemLife Spine200617—
+2K152282Cam Lock Plating SystemLife Spine, Inc.20151—
+2K130202Iris Anterior Cervical PlateLife Spine, Inc.201321—
+2K103423Mis Anterior Cervical Plating SystemLife Spine20111—
+2K093776Indus Anterior Cervical Plate SystemSpinefrontier, Inc.201016—
+2K073479Kinetic-SL Anterior Cervical Plate SystemLife Spine200852—
+3K243369Cervical Plating SystemLife Spine, Inc.20240—
+3K232605Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue®…Lesspine Innovations20230—
+3K163104Terrace™ Anterior Cervical Plate SystemCorelink, LLC201718—
+3K121060Spine Frontier Indus Acp SystemSpinefrontier, Inc.2012156
+3K100614Hallmark Anterior Cervcial Plate System, Hallmark Five-Level Cervical PlatesBlackstone Medical, Inc.201051—
+4K2117123° Anterior Cervical Plating System, Reliant Anterior Cervical Plating System, Unity…Orthofix US, LLC20220—
+4K193494Origin™ Anterior Cervical Plate SystemOrthopaedic & Spine Development20200—
+4K190016Lateral Plate SystemCorelink, LLC201915—
+4K162638CETRA Anterior Cervical Plate SystemOrthofix, Inc.20163—
+4K153526Pyrenees Cervical Plate SystemK2m20166—
+4K142060Transom Anterior Cervical PlateNeurostructures, Inc.201419—
+4K140234Aspiron Acp SystemU&I Corp.20146—
+4K130825Azure Anterior Cervical Plate SystemOrthofix, Inc.201311
+4K122216Reliance Anterior Cervical Plate SystemReliance Medical Systems, LLC20123—
+4K121658Orthofix Acp (Anterior Cervical Plate System)Orthofix, Inc.20124—
+5K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+5K231251FlexWing Anterior Cervical Plate SystemJeil Medical Corporation20242—
+5K240935ARENAL Anterior Cervical Plate SystemEffortmed, LLC20240—
+5K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+5K221572VyPlate Anterior Cervical Plate SystemVy Spine, LLC20221—
+5K203065Lumbar Spine Truss System Plating Solution (LSTS-PS)4Web, Inc.20219—
+5K202192STRUXXURE®-L and STRUXXURE®-A Plate SystemNexxt Spine, LLC20200—
+5K200927Transept Cervical Plate SystemNeurostructures, Inc.20200—
+5K191786Cyclops™ Anterior Cervical Plate SystemDegen Medical, Inc.20191—
+5K190053SECULOK™ ACP SystemU&I Corporation20191—
+5K181190Pinehurst Anterior Cervical Plate SystemSignature Orthopaedics Pty, Ltd.20190—
+5K182055SECULOK™ ACP SystemU&I Corporation20182—
+5K173521SeaSpine Cabo ACP (Anterior Cervical Plate) SystemSeaSpine Orthopedics Corporation201815—
+5K171112Trifore (tm) Cervical Plating SystemNeurostructures, Inc.20171—
+5K162664Pyrenees Cervical Plate SystemK2m, Inc.20165—
+5K143028Azure Anterior Cervical Plate SystemOrthofix, Inc.20150—
+5K140742Reliance Anterior Cervical PlateReliance Medical Systems, LLC20142—
+6K260697VyPlate™ Anterior Cervical Plate SystemVy Spine, LLC20260—
+6K253201Lumbar Spine Truss System - Plating Solution (LSTS-PS)4Web, Inc.20260—
+6K253545Vulcan Spinal SystemK2m, Inc.20260—
+6K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc.20250—
+6K252826ARIX Femur Nail SystemJeil Medical Corporation20250—
+6K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+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—
+6K220147Aspiron S ACP SystemU&I Corporation20220—
+6K213901Cyclops™ Anterior Cervical Plate SystemDegen Medical20220—
+6K212139Admiral ACP SystemSeaSpine Orthopedics Corporation20216—
+6K211903Shoreline Threaded TruProfile® PlateSeaSpine Orthopedics Corporation20217—
+6K202064Admiral ACP SystemSeaSpine Orthopedics Corporation202014—
+6K182473PYRENEES Cervical Plate System, BLUE RIDGE Cervical Plate System, OZARK Cervical Plate…K2m, Inc.20184—
+7K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+7K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+7K254182AsterOsteonic Co., Ltd.20260—
+7K252611aprevo® cervical plating systemCarlsmed, Inc.20253—
+7K251117Cervical Spine Truss System (CSTS)4Web Medical20250—
+7K233966Anterior Spine Truss System-Stand Alone (ASTS-SA)4Web Medical, Inc.20241—
+7K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+7K221728Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran™ Anterior…Stryker Corporation20221—
+8K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+8K260570corra™ cervical plating systemCarlsmed, Inc.20261—
+8K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+8K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—
+8K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+8K230424Omnia Medical Coupler-A™ Anterior Lumbar Plate System; Omnia Medical Coupler-L™ Lateral…Omnia Medical, LLC20230—
+9K262149corra® cervical plating systemCarlsmed, Inc.20260—
+9K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+9K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+9K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—