510(k) Report

Devices descending from K992344

290 later devices reach Osteonics Accp System Line Extension through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K040017Abc Caudal and Cranial Extension Plate (E-Plate)Aesculap, Inc.200413—
+1K000486Abc Cervical Plating SystemAesculap, Inc.2000289—
+2K122910Archon Anterior Cervical Plate Syste,Nu Vasive, Incorporated2012101—
+2K112809Blue Mountain Cervical PlateQualgenix, LLC20122—
+2K100243Quintex Cervical Plating SystemAesculap Implant Systems, LLC2010101
+2K090861Mambo, Model CS 18XX-XXUlrich GmbH & Co. KG20100—
+2K071990Valeo Cervical Plate SystemAmedica Corp.20071—
+2K050813Abc 2 ScrewAesculap, Inc.2005145—
+2K043066Pioneer Anterior Cervical Plate SystemPioneer Surgical Technology200527—
+2K030595Blackstone Fusion Anterior Cervical Plating SystemBlackstone Medical, Inc.200366—
+2K012184Blackstone Iii Anterior Cervical Plating SystemBlackstone Medical, Inc.200285—
+3K2117123° Anterior Cervical Plating System, Reliant Anterior Cervical Plating System, Unity…Orthofix US, LLC20220—
+3K212446NuVasive Anterior Cervical Plate SystemsNu Vasive, Incorporated20211—
+3K201587icotec Anterior Cervical Plate SystemIcotec AG20201—
+3K200523Biolign® Roto-Loc Cervical Plate SystemElite Surgical Supplies (Pty), Ltd.20200—
+3K191500NuVasive® ACP SystemNu Vasive, Incorporated20194—
+3K162638CETRA Anterior Cervical Plate SystemOrthofix, Inc.20163—
+3K150036Blue Mountain Cervical Plate SystemSpineway20151—
+3K142060Transom Anterior Cervical PlateNeurostructures, Inc.201419—
+3K141993Nakoma AcpAlliance Partners, LLC201481
+3K140234Aspiron Acp SystemU&I Corp.20146—
+3K133475Struxxure Anterior Cervical Plate and ScrewsNexxt Spine, LLC2013132—
+3K131025Archon Anterior Cervical Plate SystemNuvasive, Inc.201397—
+3K131200Aspiron Acp SystemU&I Corporation20137—
+3K121801Quintex Cervical Plating SystemAesculap Implant Systems, LLC20120—
+3K100708Pioneer Anterior Cervical Plate Model 24-SeriesPioneer Surgical Technology201012—
+3K083663PACPPioneer Surgical Technology200917—
+3K082037Seeplate Cervical Plate SystemAmedica Corp.20080—
+3K073500Active Anterior Cervical Plate SystemSanacor20080—
+3K053053Pacp SystemPioneer Surgical Technology200525—
+3K050892Hallmarktm Anterior Cervical Plate SystemBlackstone Medical, Inc.2005522
+3K040003Vertebron SCP Cervical Plate SystemVertebron, Inc.200412—
+3K022965Blackstone Classic Anterior Cervical PlateBlackstone Medical, Inc.200310—
+3K020620Blackstone Iii Degree Anterior Cervical Plating System (Plate Washer)Blackstone Medical, Inc.20021—
+3K020600Blackstone Iii Anterior Cervical Plating System (Plate Washer)Blackstone Medical, Inc.20020—
+4K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+4K231251FlexWing Anterior Cervical Plate SystemJeil Medical Corporation20242—
+4K240935ARENAL Anterior Cervical Plate SystemEffortmed, LLC20240—
+4K233215icotec Anterior Cervical Plate SystemIcotec AG20240—
+4K240690STRUXXURE® MCS Anterior Cervical Plate SystemNexxt Spine20244—
+4K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+4K212527Cervical Spine Truss System Plating Solution (CSTS-PS)4Web Medical, Inc.20220—
+4K203253NuVasive ACP SystemNu Vasive, Incorporated20202—
+4K201979Cervical Plate SystemEminent Spine, LLC20201—
+4K201521Medina Anterior Cervical Plate SystemAlliance Partners, LLC20200—
+4K200927Transept Cervical Plate SystemNeurostructures, Inc.20200—
+4K201078NuVasive® ACP SystemNu Vasive, Incorporated20203—
+4K190053SECULOK™ ACP SystemU&I Corporation20191—
+4K183060CervAlign™ Anterior Cervical Plate SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)201921
+4K181190Pinehurst Anterior Cervical Plate SystemSignature Orthopaedics Pty, Ltd.20190—
+4K182055SECULOK™ ACP SystemU&I Corporation20182—
+4K173128Alamo® CAlliance Partners, LLC20182—
+4K173521SeaSpine Cabo ACP (Anterior Cervical Plate) SystemSeaSpine Orthopedics Corporation201815—
+4K172585Liberty Anterior Cervical PlateValorus Spine20170—
+4K163104Terrace™ Anterior Cervical Plate SystemCorelink, LLC201718—
+4K171112Trifore (tm) Cervical Plating SystemNeurostructures, Inc.20171—
+4K163602Kepler I Cervical Plate SystemOrbbo Surgical, LLC20170—
+4K163061Altus Spine Cervical Plate SystemAltus Partners, LLC20171—
+4K161442NuVasive® CoRoent® Small Interlock™ SystemNu Vasive, Incorporated201694—
+4K161524Tangis Anterior Cervical PlateNvision Biomedical Technologies, LLC20168—
+4K141376Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx, Struxxure Anterior…Nexxt Spine, LLC2014106—
+4K130427Pioneer Aspect Anterior Cervical Plate SystemPioneer Surgical Technology, Inc.20135—
+4K130825Azure Anterior Cervical Plate SystemOrthofix, Inc.201311
+4K122216Reliance Anterior Cervical Plate SystemReliance Medical Systems, LLC20123—
+4K121658Orthofix Acp (Anterior Cervical Plate System)Orthofix, Inc.20124—
+4K111528Pioneer Aspect Anterior Cervical Plate Model 24-SeriesPioneer Surgical Technology, Inc.201111—
+4K100614Hallmark Anterior Cervcial Plate System, Hallmark Five-Level Cervical PlatesBlackstone Medical, Inc.201051—
+4K091396Cardo Medical Anterior Cervical Plate SystemCardo Medical Corp.20092—
+4K081567Vertebron SSP Cervical Plating SystemVertebron, Inc.20086—
+4K073530Accin Anterior Cervical Plate SystemAccelerated Innovation, LLC20083—
+4K072703Pioneer Slimfuse Anterior Cervical Plating SystemPioneer Surgical Technology200819—
+4K051815Modification to Vertebron SCP Cervical Plate SystemVertebron, Inc.200510—
+4K043181Modification to Vertebron SCP Cervical Plate SystemVertebron, Inc.200411—
+5K252611aprevo® cervical plating systemCarlsmed, Inc.20253—
+5K252826ARIX Femur Nail SystemJeil Medical Corporation20250—
+5K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+5K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+5K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+5K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+5K232605Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue®…Lesspine Innovations20230—
+5K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+5K231145Axis Anterior Cervical Plate SystemSouthern Medical (Pty), Ltd.20230—
+5K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+5K221572VyPlate Anterior Cervical Plate SystemVy Spine, LLC20221—
+5K220147Aspiron S ACP SystemU&I Corporation20220—
+5K213115CHENA-C Spacer SystemKahtnu Surgical, Inc.20210—
+5K210424Quantum Anterior Cervical PlateNvision Biomedical Technologies, Inc.20214—
+5K212139Admiral ACP SystemSeaSpine Orthopedics Corporation20216—
+5K211903Shoreline Threaded TruProfile® PlateSeaSpine Orthopedics Corporation20217—
+5K211408CervAlign® Anterior Cervical Plate SystemPioneer Surgical Technology, Inc.20211—
+5K202657Javelin Tailor's Bunion Fixation SystemNvision Biomedical Technologies, Inc.20201—
+5K202064Admiral ACP SystemSeaSpine Orthopedics Corporation202014—
+5K193494Origin™ Anterior Cervical Plate SystemOrthopaedic & Spine Development20200—
+5K191786Cyclops™ Anterior Cervical Plate SystemDegen Medical, Inc.20191—
+5K190016Lateral Plate SystemCorelink, LLC201915—
+5K183084Fuji Cervical Plate SystemAltus Partners, LLC20190—
+5K183409Athena II Cervical Plate SystemMedyssey USA, Inc.20191—
+5K181435ATEC Cervical Spacer SystemAlphatec Spine, Inc.2018100—
+5K180022Athena Cervical Plate SystemMedyssey USA, Inc.20182—
+5K173115COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and…Globus Medical, Inc.201783—