510(k) Report

Devices descending from K973854

831 later devices reach Orion Anterior Cervical Plate System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K071990Valeo Cervical Plate SystemAmedica Corp.20071—
+1K051815Modification to Vertebron SCP Cervical Plate SystemVertebron, Inc.200510—
+1K051039Basis Spinal SystemMedtronic Sofamor Danek USA, Inc.20050—
+1K042499Orion Anterior Cervical Plating SystemMedtronic Sofamor Danek2004694—
+1K042235Orion Anterior Cervical Plating SystemMedtronic Sofamor Danek2004684—
+1K013439Anterior Cervical Plate SystemScien'Tx USA, Inc.200264—
+1K990005Spinal Concepts, Inc. (Sci) Anterior Cervical Plate SystemSpinal Concepts, Inc.19993131
+2K141332Captiva Spine SmartLOX Cervical Plate SystemCaptiva Spine20151—
+2K143626inVizia Anterior Certical Plate System, SC-AcuFix Ant-Cer Dynamic Cervical Plating…Zimmer Spine, Inc.201516—
+2K132310ASCOTBackroads Consulting, Inc.20130—
+2K121514Anodyne Anterior Cervical Plate SystemCorelink, LLC201221—
+2K112809Blue Mountain Cervical PlateQualgenix, LLC20122—
+2K101848Sapphire Anterior Cervical Plate SystemSpinal Elements, Inc.20102—
+2K100265Diamond Anterior Cervical Plate SystemAmendia, Inc.201034—
+2K082037Seeplate Cervical Plate SystemAmedica Corp.20080—
+2K081567Vertebron SSP Cervical Plating SystemVertebron, Inc.20086—
+2K073530Accin Anterior Cervical Plate SystemAccelerated Innovation, LLC20083—
+2K062110Vertebron SCP Cervical Plate SystemVertebron, Inc.20069—
+2K043082The Tosca Anterior Cervical Plate SystemSignus Medizintechnik GmbH20043—
+2K042922Venture Anterior Cervical Plating SystemMedtronic Sofamor Danek, Inc.2004677—
+2K042317Cervical PlateScient'X200463—
+2K024326Spinal Concepts, Inc. Ant-Cer Dynamic Anterior Cervical Plate SystemSpinal Concepts, Inc.2003194
+2K013979SC-Acufix Thinline Anterior Cervical Plate SystemSpinal Concepts, Inc.2002212
+2K000486Abc Cervical Plating SystemAesculap, Inc.2000289—
+3K240592Wolff's Law Anterior Cervical Plate SystemSpinal Simplicity, LLC20240—
+3K223321Omnia Medical Coupler-C Anterior Cervical PlateOmnia Medical, LLC20230—
+3K223719Paeon Anterior Cervical Plate System, Elatus Lumbar Plate SystemAegis Spine, Inc.20233—
+3K200301UNiTi ACDF Implant SystemPressio, Inc.20210—
+3K202972Anterior Cervical Plate SystemNutech Spine and Biologics20200—
+3K192481AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd.202013—
+3K201029Sapphire® Spinal System, Sapphire X Anterior Cervical Plate Spinal SystemSpinal Elements, Inc.20201—
+3K183409Athena II Cervical Plate SystemMedyssey USA, Inc.20191—
+3K182885Atlantis™ Anterior Cervical Plate, Divergence™ Anterior Cervical Fusion System, Premier™…Medtronic Sofamor Danek USA, Inc.20198—
+3K181190Pinehurst Anterior Cervical Plate SystemSignature Orthopaedics Pty, Ltd.20190—
+3K180022Athena Cervical Plate SystemMedyssey USA, Inc.20182—
+3K171797TRYPTIK2 C-Plate Anterior Cervical Plate SystemSpineart20180—
+3K163104Terrace™ Anterior Cervical Plate SystemCorelink, LLC201718—
+3K163061Altus Spine Cervical Plate SystemAltus Partners, LLC20171—
+3K153042TRYPTIK2C-plate Anterior Cervical Plate SystemSpineart201617
+3K150036Blue Mountain Cervical Plate SystemSpineway20151—
+3K132994Anodyne Anterior Cervical Plate SystemCorelink, LLC20131—
+3K122910Archon Anterior Cervical Plate Syste,Nu Vasive, Incorporated2012101—
+3K113329K2M, Pyrenees Cervical Plate SystemK2m, Inc.201228—
+3K100243Quintex Cervical Plating SystemAesculap Implant Systems, LLC2010101
+3K090861Mambo, Model CS 18XX-XXUlrich GmbH & Co. KG20100—
+3K100215Archimed Remedy Cervical PlateArchimed, Inc.20100—
+3K091396Cardo Medical Anterior Cervical Plate SystemCardo Medical Corp.20092—
+3K073500Active Anterior Cervical Plate SystemSanacor20080—
+3K071033T2 XVBR Spinal SystemMedtronic Sofamor Danek200750—
+3K070681Next Generation Anterior Cervical Plating SystemAlphatec Spine, Inc.2007621
+3K061274Venture Anterior Cervical Plate SystemMedtronic Sofamor Danek2006669—
+3K052072The SC-Acufix Ant-Cer Dynamic Cervical Plate System Single Level PlatesAbbott Spine, Inc.200517—
+3K050813Abc 2 ScrewAesculap, Inc.2005145—
+3K043066Pioneer Anterior Cervical Plate SystemPioneer Surgical Technology200527—
+3K040017Abc Caudal and Cranial Extension Plate (E-Plate)Aesculap, Inc.200413—
+3K030595Blackstone Fusion Anterior Cervical Plating SystemBlackstone Medical, Inc.200366—
+3K012184Blackstone Iii Anterior Cervical Plating SystemBlackstone Medical, Inc.200285—
+4K251940PathLoc Lumbar Plate SystemL&K BIOMED Co., Ltd.20260—
+4K232605Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue®…Lesspine Innovations20230—
+4K231593Sapphire X3 Anterior Cervical Plate SystemSpinal Elements, Inc.20230—
+4K231839CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd.20232—
+4K231145Axis Anterior Cervical Plate SystemSouthern Medical (Pty), Ltd.20230—
+4K230301Athena III Cervical Plate SystemMedyssey USA, Inc.20230—
+4K220843OAKTREE Anterior Lumbar Plate and Screw SystemOak Tree Engineering, LLC20220—
+4K2117123° Anterior Cervical Plating System, Reliant Anterior Cervical Plating System, Unity…Orthofix US, LLC20220—
+4K212446NuVasive Anterior Cervical Plate SystemsNu Vasive, Incorporated20211—
+4K211932Fixxsure Anterior Lumbar Plate and Screw SystemOak Tree Engineering, LLC20211—
+4K210035ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix…Aegis Spine202110—
+4K201587icotec Anterior Cervical Plate SystemIcotec AG20201—
+4K200523Biolign® Roto-Loc Cervical Plate SystemElite Surgical Supplies (Pty), Ltd.20200—
+4K193494Origin™ Anterior Cervical Plate SystemOrthopaedic & Spine Development20200—
+4K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+4K191584FORTICO Anterior Cervical Fixation SystemCamber Spine Technologies, LLC20192—
+4K191500NuVasive® ACP SystemNu Vasive, Incorporated20194—
+4K190016Lateral Plate SystemCorelink, LLC201915—
+4K183084Fuji Cervical Plate SystemAltus Partners, LLC20190—
+4K183510T2 STRATOSPHERE Expandable Corpectomy SystemMedtronic Sofamor Danek USA, Inc.201927—
+4K182473PYRENEES Cervical Plate System, BLUE RIDGE Cervical Plate System, OZARK Cervical Plate…K2m, Inc.20184—
+4K173125T2 STRATOSPHERE™ Expandable Corpectomy SystemMedtronic Sofamor Danek201747—
+4K163602Kepler I Cervical Plate SystemOrbbo Surgical, LLC20170—
+4K162638CETRA Anterior Cervical Plate SystemOrthofix, Inc.20163—
+4K142060Transom Anterior Cervical PlateNeurostructures, Inc.201419—
+4K141993Nakoma AcpAlliance Partners, LLC201481
+4K140234Aspiron Acp SystemU&I Corp.20146—
+4K133475Struxxure Anterior Cervical Plate and ScrewsNexxt Spine, LLC2013132—
+4K131025Archon Anterior Cervical Plate SystemNuvasive, Inc.201397—
+4K131200Aspiron Acp SystemU&I Corporation20137—
+4K130202Iris Anterior Cervical PlateLife Spine, Inc.201321—
+4K121862Rex Anterior Cervical Plate SystemDio Medical Co., Ltd.20127—
+4K121801Quintex Cervical Plating SystemAesculap Implant Systems, LLC20120—
+4K112533Zavation Cervical Plate SystemZavation, LLC201126—
+4K102820Appliance, Fixation, Spinal Intervertebral BodyAlphatec Spine, Inc.2010382
+4K100976T2 XVBR 1.5 Spinal SystemMedtronic Sofamor Danek USA, Inc.201049—
+4K100708Pioneer Anterior Cervical Plate Model 24-SeriesPioneer Surgical Technology201012—
+4K083663PACPPioneer Surgical Technology200917—
+4K073285Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek USA, Inc.2008637—
+4K053053Pacp SystemPioneer Surgical Technology200525—
+4K050892Hallmarktm Anterior Cervical Plate SystemBlackstone Medical, Inc.2005522
+4K040003Vertebron SCP Cervical Plate SystemVertebron, Inc.200412—
+4K022965Blackstone Classic Anterior Cervical PlateBlackstone Medical, Inc.200310—