510(k) Report

Devices descending from K973854

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K020620Blackstone Iii Degree Anterior Cervical Plating System (Plate Washer)Blackstone Medical, Inc.20021—
+4K020600Blackstone Iii Anterior Cervical Plating System (Plate Washer)Blackstone Medical, Inc.20020—
+5K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.20260—
+5K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+5K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+5K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+5K241164IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic)202412
+5K231251FlexWing Anterior Cervical Plate SystemJeil Medical Corporation20242—
+5K240935ARENAL Anterior Cervical Plate SystemEffortmed, LLC20240—
+5K233215icotec Anterior Cervical Plate SystemIcotec AG20240—
+5K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+5K240690STRUXXURE® MCS Anterior Cervical Plate SystemNexxt Spine20244—
+5K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+5K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+5K231840CastleLoc-S Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd.20230—
+5K231841PathLoc SI Joint Fusion SystemL&K BIOMED Co., Ltd.20231—
+5K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+5K223521ZESPIN SI Joint Fusion SystemAegis Spine, Inc.20232—
+5K221728Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran™ Anterior…Stryker Corporation20221—
+5K222572FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, and…Dio Medical Corporation20222—
+5K221050ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior…Aegis Spine, Inc.20226—
+5K212527Cervical Spine Truss System Plating Solution (CSTS-PS)4Web Medical, Inc.20220—
+5K210470C-CURVE Interbody Fusion DeviceMedicrea International SA20210—
+5K211205Prase-C Anterior Cervical Plate SystemGbs Commonwealth Co., Ltd.20210—
+5K203065Lumbar Spine Truss System Plating Solution (LSTS-PS)4Web, Inc.20219—
+5K203253NuVasive ACP SystemNu Vasive, Incorporated20202—
+5K202192STRUXXURE®-L and STRUXXURE®-A Plate SystemNexxt Spine, LLC20200—
+5K201979Cervical Plate SystemEminent Spine, LLC20201—
+5K201521Medina Anterior Cervical Plate SystemAlliance Partners, LLC20200—
+5K200927Transept Cervical Plate SystemNeurostructures, Inc.20200—
+5K200995Insignia™ Anterior Cervical Plate SystemAlphatec Spine, Inc.2020729
+5K201078NuVasive® ACP SystemNu Vasive, Incorporated20203—
+5K191066CD Horizon™ Astute™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201921—
+5K191039Navigated T2 STRATOSPHERE Inserters and Navigated TemplatesMedtronic Sofamor Danek USA, Inc.201918—
+5K190053SECULOK™ ACP SystemU&I Corporation20191—
+5K183060CervAlign™ Anterior Cervical Plate SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)201921
+5K181328T2 STRATOSPHERE™ Expandable Corpectomy SystemMedtronic Sofamor Danek USA, Inc.201828—
+5K182055SECULOK™ ACP SystemU&I Corporation20182—
+5K181244Zavation Cervical Plate SystemZavation Medical Products, LLC20187—
+5K180537Zavation Buttress Plate SystemZavation Medical Products, LLC20180—
+5K173128Alamo® CAlliance Partners, LLC20182—
+5K173521SeaSpine Cabo ACP (Anterior Cervical Plate) SystemSeaSpine Orthopedics Corporation201815—
+5K173306EZ PlateZavation Medical Products, LLC20180—
+5K173099Fortis and Hana Anterior Cervical Plate SystemHuvexel Co., Ltd.20174—
+5K172585Liberty Anterior Cervical PlateValorus Spine20170—
+5K171112Trifore (tm) Cervical Plating SystemNeurostructures, Inc.20171—
+5K162531Sterispine CCSafe Orthopaedics20160—
+5K161442NuVasive® CoRoent® Small Interlock™ SystemNu Vasive, Incorporated201694—
+5K161524Tangis Anterior Cervical PlateNvision Biomedical Technologies, LLC20168—
+5K153373CORNERSTONE PSR Cervical Fusion System, PERIMETER C Spinal System, PEEK PREVAIL Cervical…Medtronic Sofamor Danek2016110—
+5K152282Cam Lock Plating SystemLife Spine, Inc.20151—
+5K152193Renovis Anterior Cervical Plate SystemRenovis Surgical Technologies, Inc.20154—
+5K150666uNion Cervical Plate SystemUlrich Medical USA201531
+5K142218Coalition AGX Plate and Coalition AGX SpacerGlobus Medical, Inc.2015155—
+5K142940Endoskeleton TCS SystemTitan Spine, LLC20151112
+5K141376Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx, Struxxure Anterior…Nexxt Spine, LLC2014106—
+5K133494Chesapeake Spinal SystemK2m, Inc.2014330—
+5K131888T2 XVBR Spinal System, T2 Altitude Expandable Corpectomy DeviceMedtronic Sofamor Danek, Inc.20130—
+5K132366Spinal Intervertebral Body Fixation OrthosisAccel Spine20130—
+5K131520Nexus Anterior Cervical Plate SystemCore-Nexus20130—
+5K130427Pioneer Aspect Anterior Cervical Plate SystemPioneer Surgical Technology, Inc.20135—
+5K130825Azure Anterior Cervical Plate SystemOrthofix, Inc.201311
+5K130030Zavation Cervical Plate SystemZavation, LLC201315—
+5K122037Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion System Peek Prevail…Medtronic Sofamor Danek, Inc.2013281—
+5K122216Reliance Anterior Cervical Plate SystemReliance Medical Systems, LLC20123—
+5K121658Orthofix Acp (Anterior Cervical Plate System)Orthofix, Inc.20124—
+5K120275Synthes Acis/Vertebral Spacer CRSynthes (Usa), LLC2012173—
+5K112459Synthes Zero-PSynthes Spine Co.Lp2011277—
+5K111132Genesys Spine Anterior Cervical Plate SystemGenesys Spine201141
+5K112068Synthes Zero-P Variable Angle (VA)Synthes Spine Co.Lp2011331
+5K111528Pioneer Aspect Anterior Cervical Plate Model 24-SeriesPioneer Surgical Technology, Inc.201111—
+5K100967Perimeter C Spinal SystemMedtronic Sofamor Danek USA, Inc.2011121—
+5K103137Venus Anterior Cervical PlateVerticor, Ltd.20115—
+5K102323Cervical Standalone Intervertebral Body Fusion DeviceTheken Spine, LLC201062—
+5K094042Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek2010397—
+5K100214Cornerstone PSR Cervical Interbody Fusion DeviceMedtronic Sofamor Danek2010389—
+5K100614Hallmark Anterior Cervcial Plate System, Hallmark Five-Level Cervical PlatesBlackstone Medical, Inc.201051—
+5K072703Pioneer Slimfuse Anterior Cervical Plating SystemPioneer Surgical Technology200819—
+5K043181Modification to Vertebron SCP Cervical Plate SystemVertebron, Inc.200411—
+6K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+6K253213SAGI Cervical Cage SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+6K253201Lumbar Spine Truss System - Plating Solution (LSTS-PS)4Web, Inc.20260—
+6K253545Vulcan Spinal SystemK2m, Inc.20260—
+6K252611aprevo® cervical plating systemCarlsmed, Inc.20253—
+6K253577IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)Medicrea International S.A.S. (Medtronic)20250—
+6K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc.20250—
+6K252826ARIX Femur Nail SystemJeil Medical Corporation20250—
+6K250764SpineLinc Anterior Cervical Implant SystemLincotek Medical20250—
+6K250769Dakota LP SystemPrecision Spine, Inc.20250—
+6K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+6K250446Frida™ Anterior Cervical Plate SystemSpineup, Inc.20250—
+6K243369Cervical Plating SystemLife Spine, Inc.20240—
+6K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+6K242195Gemini Cervical Fusion Cage SystemZheJiang Decans Medical Devices Co., Ltd.20241—
+6K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc.20241—
+6K240515uNion® MAX Cervical Plate SystemUlrich Medical USA, Inc.20240—
+6K240201PathLoc SI Joint Fusion SystemL&K BIOMED Co., Ltd.20240—
+6K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+6K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+6K232318VICTORY™ Lumbar Plate SystemGlobus Medical, Inc.20230—