510(k) Report

Devices descending from K994347

343 later devices reach Centaur Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K150449LITe Plate SystemStryker Corp.201524—
+1K142699LITe Plate SystemStryker Corporation201446—
+1K080773Thor Anterior Plating SystemStryker Spine2008101—
+1K073437Thor Anterior Plating SystemStryker Spine200810231
+1K002824Macs Modular Anterior Construct SystemAesculap, Inc.2001254—
+2K241175MiRus MoRe Lumbar Plating SystemMiRus, LLC20240—
+2K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+2K233360Curiteva Thoracolumbar Plate SystemCuriteva, Inc.20240—
+2K232318VICTORY™ Lumbar Plate SystemGlobus Medical, Inc.20230—
+2K223719Paeon Anterior Cervical Plate System, Elatus Lumbar Plate SystemAegis Spine, Inc.20233—
+2K221728Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran™ Anterior…Stryker Corporation20221—
+2K220324AccuFit Lateral 2-Hole PlatePrecision Spine, Inc.20223—
+2K192481AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd.202013—
+2K190016Lateral Plate SystemCorelink, LLC201915—
+2K190584CAYMAN LP Plate SystemK2m, Inc.20192—
+2K183214Raven Lumbar Plate SystemChoicespine, LP20192—
+2K173885Genesys Spine Binary Lumbar Plate SystemGenesys Spine20184—
+2K123939S4 Spinal SystemAesculap Implant Systems, Inc.20133—
+2K101353Golden Gate Anterior Plate SystemUlrich GmbH & Co. KG20110—
+2K091253Thoracolumbar Plate, Model 1208-41FXX, Lumber Plate, Model 1208-41FXXL, Sacral Plate…K2m, Inc.200973—
+2K032059Modification to Macs Modular Anterior Construct SystemAesculap, Inc.2003250—
+3K260015ANTERIS Thoracolumbar Plate SystemSpineCraft20260—
+3K251940PathLoc Lumbar Plate SystemL&K BIOMED Co., Ltd.20260—
+3K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+3K241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc.20241—
+3K231715MONDRIAN™ Anterior Lumbar Plate SystemCtl Medical Corporation20240—
+3K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+3K231839CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd.20232—
+3K230424Omnia Medical Coupler-A™ Anterior Lumbar Plate System; Omnia Medical Coupler-L™ Lateral…Omnia Medical, LLC20230—
+3K220843OAKTREE Anterior Lumbar Plate and Screw SystemOak Tree Engineering, LLC20220—
+3K211932Fixxsure Anterior Lumbar Plate and Screw SystemOak Tree Engineering, LLC20211—
+3K203065Lumbar Spine Truss System Plating Solution (LSTS-PS)4Web, Inc.20219—
+3K210035ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix…Aegis Spine202110—
+3K202192STRUXXURE®-L and STRUXXURE®-A Plate SystemNexxt Spine, LLC20200—
+3K192678Genesys Spine Binary® Lumbar Plate SystemGenesys Spine20191—
+3K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+3K131533Cayman MI Plate SystemK2m, Inc.201372—
+3K070387Expedium Spine SystemDepuy Spine, Inc.2007248—
+4K261810Vertiwedge® Intraosseous SystemFoundation Surgical Group20260—
+4K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.20260—
+4K253201Lumbar Spine Truss System - Plating Solution (LSTS-PS)4Web, Inc.20260—
+4K253545Vulcan Spinal SystemK2m, Inc.20260—
+4K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc.20250—
+4K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc.20241—
+4K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+4K231739Cervical Spine Truss System (CSTS)4Web Medical, Inc.20232—
+4K231840CastleLoc-S Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd.20230—
+4K231841PathLoc SI Joint Fusion SystemL&K BIOMED Co., Ltd.20231—
+4K223362Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device4Web Medical, Inc.20233—
+4K223521ZESPIN SI Joint Fusion SystemAegis Spine, Inc.20232—
+4K221050ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior…Aegis Spine, Inc.20226—
+4K212527Cervical Spine Truss System Plating Solution (CSTS-PS)4Web Medical, Inc.20220—
+4K182473PYRENEES Cervical Plate System, BLUE RIDGE Cervical Plate System, OZARK Cervical Plate…K2m, Inc.20184—
+4K180433Ennovate®Aesculap Implant Systems, LLC201811
+4K172941CASCADIA Interbody SystemK2m201852—
+4K142185Expedium Verse Spine SystemDepuy Spine, Inc.201420—
+4K111571Viper SystemsJohnson & Johnson2011203—
+4K102249Expedium Spine SystemDepuy Spine, A Johnson & Johnson Company2010218—
+4K073430Valeo Pedicle Screw Spinal SystemAmedica Corp.200824—
+5K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+5K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+5K251117Cervical Spine Truss System (CSTS)4Web Medical20250—
+5K233966Anterior Spine Truss System-Stand Alone (ASTS-SA)4Web Medical, Inc.20241—
+5K240201PathLoc SI Joint Fusion SystemL&K BIOMED Co., Ltd.20240—
+5K230961Zeus Spinal SystemShanghai Sanyou Medical Co, Ltd.20232—
+5K232154MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate FixationMiRus, LLC20230—
+5K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+5K222806Kodiak C Spinal Implant SystemMet One Technologies, LLC20221—
+5K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+5K200245EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine SystemMedos International Sàrl202012—
+5K200267LOSPA® IS™ Spinal Fixation SystemCorentec Co., Ltd.20201—
+5K191212CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated…Medos International SARL20190—
+5K191354Ti3Z Cervical Interbody SystemZavation Medical Products, LLC201913—
+5K182210TiWAVE-L Porous Titanium Lumbar CageKalitec Medical, LLC20193—
+5K182239OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20182—
+5K182240PASS LP Spinal SystemMedicrea International SA20182—
+5K181347Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC201824—
+5K162160Preference Elite Pedicle Screw SystemAmedica Corporation20161—
+5K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A.20162—
+5K142835Iliad Pedicle Screw System and Zenius Pedicle Screw SystemMedyssey USA, Inc.20155—
+5K143683APEX-DL Spine SystemSpinecraft, LLC20153—
+5K133575Spinevision Lumis Cannulated Pedicle Screw Fixation System, Spinevision U.L.I.S. Pedicle…Spinevision S.A.20143—
+5K131810Osseus Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLC201314—
+5K121728Tiger Spine SystemCorelink, LLC201250—
+5K121172Reform Pedicle Screw SystemSpinal USA201233—
+5K121016Range Spinal System (Mesa and Denali)K2m, Inc.201238—
+5K121020Viper SystemDepuy Spine, Inc.201294—
+5K120696Tiger Spine SystemCorelink, LLC201241—
+5K080767Conquest Spinal SystemLife Spine200821—
+6K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+6K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+6K260340HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC…HC Biologics, LLC20260—
+6K252711Advantage-C™ Ti3D Cervical Interbody Fusion DeviceIntelivation Technologies20260—
+6K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+6K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+6K253249TriALTIS™ Spine SystemMedos International SARL20251—
+6K252437JAZZ Spinal SystemImplanet20250—
+6K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—
+6K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+6K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd.20240—