510(k) Report

Devices descending from K973854

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K231739Cervical Spine Truss System (CSTS)4Web Medical, Inc.20232—
+6K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+6K231460FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System…K&J Consulting Corp.20230—
+6K230424Omnia Medical Coupler-A™ Anterior Lumbar Plate System; Omnia Medical Coupler-L™ Lateral…Omnia Medical, LLC20230—
+6K221053Magnes-C Anterior Cervical Plate SystemFellowship of Orthopaedic Researchers, Inc.20230—
+6K223362Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device4Web Medical, Inc.20233—
+6K220334MONET Anterior Cervical Plate SystemCtl Medical Corporation20220—
+6K221646CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™…Medtronic Sofamor Danek USA, Inc.202220—
+6K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+6K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+6K221572VyPlate Anterior Cervical Plate SystemVy Spine, LLC20221—
+6K220379IMPEACE and IMPEACE-Uni Anterior Cervical Plate SystemMedynus, Inc.20220—
+6K220147Aspiron S ACP SystemU&I Corporation20220—
+6K212266FIX-C PEEK Anterior Cervical Interbody SystemJeil Medical Corporation20217—
+6K213443Insignia™ Anterior Cervical Plate SystemAlphatec Spine, Inc.20216—
+6K213115CHENA-C Spacer SystemKahtnu Surgical, Inc.20210—
+6K210424Quantum Anterior Cervical PlateNvision Biomedical Technologies, Inc.20214—
+6K212139Admiral ACP SystemSeaSpine Orthopedics Corporation20216—
+6K211903Shoreline Threaded TruProfile® PlateSeaSpine Orthopedics Corporation20217—
+6K211408CervAlign® Anterior Cervical Plate SystemPioneer Surgical Technology, Inc.20211—
+6K200458Tailored-C Cervical Interbody Fusion SystemBespoke Technologies20203—
+6K202657Javelin Tailor's Bunion Fixation SystemNvision Biomedical Technologies, Inc.20201—
+6K202227Artus™ cervical plate systemUlrich GmbH & Co. KG20200—
+6K202064Admiral ACP SystemSeaSpine Orthopedics Corporation202014—
+6K192906Mecta-C Stand AloneMedacta International S.A.20201—
+6K200170SpineNet SSP SystemSpinenet, LLC20200—
+6K192336Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.201917—
+6K192208CORNICE Cervical Spacer SystemLegend Spine Technologies20190—
+6K191243HEDRON Cervical SpacersGlobus Medical, Inc.201936—
+6K191786Cyclops™ Anterior Cervical Plate SystemDegen Medical, Inc.20191—
+6K190885Elevation Spine Saber-C SystemElevation Spine201925—
+6K191565Endoskeleton TCS Interbody Fusion DeviceTitan Spine, Inc.201901
+6K180909REVEL SpacersGlobus Medical, Inc.201837—
+6K181140Axis Chena Cervical PEEK Spacer SystemAxis Orthopaedics20182—
+6K181229TirboLOX-C Cervical IBFDCaptiva Spine, Inc.20180—
+6K181435ATEC Cervical Spacer SystemAlphatec Spine, Inc.2018100—
+6K181549Curiteva Midline Anterior Cervical Plate System (or Curiteva Anterior Cervical Plate…Curiteva, LLC20180—
+6K180364HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC2018106—
+6K173722PATRIOT COLONIAL Spacer, SUSTAIN SpacerGlobus Medical, Inc.201894—
+6K172320Neurostructures Cavetto® Cervical Cage SystemNeurostructures, Inc.20183—
+6K172926SeaSpine Vu cPOD, Zuma-C, Complete CervicalSeaSpine Orthopedics Corporation201761—
+6K172185Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20177—
+6K173115COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and…Globus Medical, Inc.201783—
+6K173091Boundary Anterior Lumbar Buttress PlateNvision Biomedical Technologies, LLC20170—
+6K172019Brisbane ALIF Device, Gladstone ALIF DeviceSignature Orthopaedics Pty, Ltd.20170—
+6K172328SOVEREIGN™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201730—
+6K163366Shanghai Sanyou CARMEN Cervical Fusion SystemShanghai Sanyou Medical Co, Ltd.20170—
+6K171689ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2017109—
+6K172065Scarlet AC-TSpineart20172—
+6K171107CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal SystemMedtronic Sofamor Danek USA, Inc.20178—
+6K163422Shanghai Sanyou PEEK Cage SystemShanghai Sanyou Medical Co, Ltd.20173—
+6K172104Ozark (tm) Cervical Plate SystemK2m, Inc.20175—
+6K170318NeoFuse Ti3D PLIF/TLIF/Cervical InterbodyHt Medical, LLC201749—
+6K170961NuVasive CoRoent Small Interlock II SystemNu Vasive, Incorporated201718—
+6K152022SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION®…Globus Medical, Inc.2017149—
+6K1624024CIS® Marlin ACIF Cage SystemSolco Biomedical Co., Ltd.20171—
+6K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+6K160125Cascadia Interbody SystemK2m2016315—
+6K152793Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.201629—
+6K153122Endoskeleton (r) TCS SystemTitan Spine, LLC20151061
+6K152455Amendia Cervical Plate SystemAmendia, Inc.20151—
+6K151596Endoskeleton TCS Interbody Fusion DeviceTitan Spine, LLC20151101
+6K151408LOSPA IS Spinal SystemCorentec Co., Ltd.20151—
+6K150135DIVERGENCE-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc.2015228—
+6K142559ELEVATE Spinal SystemMedtronic Sofamor Danek USA, Inc.2015130—
+6K143028Azure Anterior Cervical Plate SystemOrthofix, Inc.20150—
+6K142487Chesapeake Stabilization SystemK2m, Inc.201571
+6K143214SCARLET® AC-T Secured Anterior Cervical CageSpineart20153—
+6K141599Divergence Anterior Cervical Fusion SystemMedtronic Sofamor Danek USA, Inc.201516—
+6K133245Genesys Spine Anterior Cervical Plate II SystemGenesys Spine201411
+6K141314Scarlet AC-T Secured Anterior Cervical Cage and Associated InstrumentationSpineart201438—
+6K140417Divergence Mini-Plate Anterior Cervical Fusion SystemMedtronic Sofamor Danek, Inc.201411—
+6K140742Reliance Anterior Cervical PlateReliance Medical Systems, LLC20142—
+6K133205Capstone PTC Spinal System, Clydesdale PTC Spinal SystemMedtronic Sofamor Danek USA, Inc.2014124—
+6K133645Perimeter C Spinal System, Capstone Spinal System, Capstone L Spinal System, Perimeter…Medtronic Sofamor Danek USA, Inc.20146—
+6K132584Perimeter C Spinal SystemMedtronic Sofamor Danek USA, Inc.2013119—
+6K130853Idys (TM) CClariance20132—
+6K131512Katia SystemShanghai Sanyou Medical Co, Ltd.20131—
+6K131449Coalition SpacerGlobus Medical, Inc.2013235—
+6K121852Synthes Zero-P Variable Angle (VA)Synthes Spine Co.Lp201230—
+6K113252Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek2012306—
+6K112388Lanx Cervical SALanx, Inc.201126—
+6K112444Anatomic Peek Cervical Fusion SystemMedtronic Sofamor Danck USA, Inc.2011324—
+6K110442Nanovis Intervertebral Body Fusion SystemNanovis, LLC201110—
+6K111264Cornerstone (R) PSR Cervical Fusion SystemMedtronic Sofamor Danek USA2011331—
+6K102547Coroent Interlock SystemNuvasive, Inc.2011131—
+7K261408SABER-XA SystemElevation Spine20260—
+7K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+7K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+7K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+7K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+7K260660SABER-C SystemElevation Spine20261—
+7K260570corra™ cervical plating systemCarlsmed, Inc.20261—
+7K253260ORIO-3D Cage SystemSpineCraft20260—
+7K242303MOD-COrthomod, LLC20260—
+7K260697VyPlate™ Anterior Cervical Plate SystemVy Spine, LLC20260—
+7K260291Vortex5 Tailor's Bunion Correction SystemNvision Biomedical Technologies, Inc.20260—
+7K254017SWINGO-3D Lumbar Cage SystemImplanet20260—
+7K254182AsterOsteonic Co., Ltd.20260—
+7K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—