510(k) Report

Devices descending from K922543

640 later devices reach Z-Plate Anterior Fixation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K160982Sphynx™Eden Spine, LLC20160—
+1K133194Diamond Rattlesnake SystemEminent Spine201417—
+1K131533Cayman MI Plate SystemK2m, Inc.201372—
+1K101353Golden Gate Anterior Plate SystemUlrich GmbH & Co. KG20110—
+1K092765Lanx Anterior Plating SystemLanx, Inc.20101—
+1K100061Cayman Screws Model K2-12-1000-XX, K2-12-1001-XXK2m, Inc.201073—
+1K091253Thoracolumbar Plate, Model 1208-41FXX, Lumber Plate, Model 1208-41FXXL, Sacral Plate…K2m, Inc.200973—
+1K051039Basis Spinal SystemMedtronic Sofamor Danek USA, Inc.20050—
+1K013665Pyramid Anterior Plate Fixation SystemMedtronic Sofamor Danek, Inc.2002248—
+1K014267Butterfly Plate Fixation SystemMedtronic Sofamor Danek, Inc.2002278—
+1K990959K-Centrum Anterior Spinal Fixation SystemSpineology, Inc.1999294—
+2K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+2K202309Epic Anterior Thoracolumbar Plate System, Gallery Laminoplasty Fixation System, Concero…Zimmer Biomet Spine, Inc.20200—
+2K192492EL CAPITAN Anterior Lumber Interbody SystemAstura Medical, LLC202010—
+2K190016Lateral Plate SystemCorelink, LLC201915—
+2K182473PYRENEES Cervical Plate System, BLUE RIDGE Cervical Plate System, OZARK Cervical Plate…K2m, Inc.20184—
+2K172941CASCADIA Interbody SystemK2m201852—
+2K1721312 Hole Lateral Plating SystemLife Spine, Inc.201710—
+2K163625NOOSA Anterior Lumbar Plate System;NAMBUCCA Anterior Lumbar Plate System; CAIRNS…Signature Orthopaedics Pty, Ltd.20172—
+2K162211AccuFit Lateral Plate SystemPrecision Spine, Inc.20164—
+2K153097Belvedere™ Lateral Plating SystemNeurostructures, Inc.20160—
+2K124034Mectalif AnteriorMedacta International201311—
+2K080429Modificaton to: Pyramid +4 Anterior Lumbar Plate SystemMedtronic Sofamor Danek USA, Inc.200850—
+2K070922Modification to Spinal Usa VBR SystemSpinal USA2007161—
+2K062836Citadel Anterior Lumbar Plate SystemGlobus Medical, Inc.200650—
+2K052546Aegis Anterior Lumbar Plate SystemDepuy Spine, Inc.2006211—
+2K051764T-Plate Anterior Fixation SystemEsm Technologies20051—
+2K043548Blackstone Unity Anterior Lumbar Plate Fixation SystemBlackstone Medical, Inc.2005211—
+2K050117Modification to Pyramid Anterior Plate Fixation SystemMedtronic Sofamor Danek20051—
+2K032059Modification to Macs Modular Anterior Construct SystemAesculap, Inc.2003250—
+2K022070Xantus Anterior Lateral Supplemental Fixation SystemMedtronic Sofamor Danek, Inc.2002277—
+2K021226Modification to Pyramid Anterior Plate Fixation SystemMedtronic Sofamor Danek20020—
+2K011556Macs Hma Anterior Spinal Stabilization SystemAesculap, Inc.2001293—
+3K254202MectaLIF 3D Metal AnteriorMedacta International S.A.20260—
+3K253545Vulcan Spinal SystemK2m, Inc.20260—
+3K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+3K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+3K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+3K232318VICTORY™ Lumbar Plate SystemGlobus Medical, Inc.20230—
+3K232154MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate FixationMiRus, LLC20230—
+3K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+3K222554EL CAPITAN Anterior Lumbar Interbody FusionAstura Medical20235—
+3K222806Kodiak C Spinal Implant SystemMet One Technologies, LLC20221—
+3K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc.20221—
+3K221545MectaLIF Anterior ExtensionMedacta International S.A.202226
+3K221728Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran™ Anterior…Stryker Corporation20221—
+3K214047EL CAPITAN Anterior Lumbar Interbody Fusion SystemAstura Medical20223—
+3K220324AccuFit Lateral 2-Hole PlatePrecision Spine, Inc.20223—
+3K212937Dakota ALIF Plate SystemPrecision Spine, Inc.20210—
+3K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+3K203065Lumbar Spine Truss System Plating Solution (LSTS-PS)4Web, Inc.20219—
+3K202192STRUXXURE®-L and STRUXXURE®-A Plate SystemNexxt Spine, LLC20200—
+3K201079Aurora® Anterior Lumbar Plate SytstemPrism Surgical Design Pty, Ltd.20200—
+3K200048MectaLIF Anterior SimpleMedacta International S.A.20200—
+3K192906Mecta-C Stand AloneMedacta International S.A.20201—
+3K192281AEGIS Anterior Lumbar Plate System, ALC Dynamized Fixation System, Anterior ISOLA Spine…Medos International SARL20190—
+3K191354Ti3Z Cervical Interbody SystemZavation Medical Products, LLC201913—
+3K181190Pinehurst Anterior Cervical Plate SystemSignature Orthopaedics Pty, Ltd.20190—
+3K182210TiWAVE-L Porous Titanium Lumbar CageKalitec Medical, LLC20193—
+3K181846ASSURE Anterior Cervical Plate System, PROVIDENCE Anterior Cervical Plate System, VIP…Globus Medical, Inc.20184—
+3K181347Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC201824—
+3K180166Life Spine Lumbar Fixation System (SENTRY)Life Spine, Inc.20189—
+3K173885Genesys Spine Binary Lumbar Plate SystemGenesys Spine20184—
+3K172019Brisbane ALIF Device, Gladstone ALIF DeviceSignature Orthopaedics Pty, Ltd.20170—
+3K160605MectaLIF Anterior Stand-AloneMedacta International201610—
+3K142699LITe Plate SystemStryker Corporation201446—
+3K132589Anterior Lumbar Plate System (Presidio)Life Spine, Inc.201312—
+3K121791Zou Anterior Lumbar Plate SystemCorelink, LLC2012113—
+3K121323Medicrea International Anterior Lumbar PlateMedicrea International20120—
+3K111866Nuvasive Anterior Lumbar Plate SystemNuvasive, Inc.201135—
+3K111410Nuvasive Long Lateral Spinal SystemNuvasive, Inc.20111—
+3K101255Alphatec Spine Anterior Lumbar Plating SystemAlphatec Spine, Inc.2010113—
+3K091044Spinal Usa Anterior Lumbar Plate SystemSpinal USA2009159—
+3K072231The Translation Plate Phase 1 (T-1 Plate) and Phase 2 (T-2 Plate)Esm Technologies, LLC20070—
+3K071416Pyramid +4 Anterior Lumbar Spine Plate SystemMedtronic Sofamor Danek USA, Inc.2007276—
+3K070387Expedium Spine SystemDepuy Spine, Inc.2007248—
+3K061229Unity LX Anterolateral Lumbar Plate Fixation SystemBlackstone Medical, Inc.2006165—
+4K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+4K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+4K260340HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC…HC Biologics, LLC20260—
+4K260015ANTERIS Thoracolumbar Plate SystemSpineCraft20260—
+4K251940PathLoc Lumbar Plate SystemL&K BIOMED Co., Ltd.20260—
+4K253201Lumbar Spine Truss System - Plating Solution (LSTS-PS)4Web, Inc.20260—
+4K252711Advantage-C™ Ti3D Cervical Interbody Fusion DeviceIntelivation Technologies20260—
+4K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc.20250—
+4K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+4K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc.20250—
+4K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+4K250603AxTiHA® Stand-Alone ALIF SystemInnovasis20250—
+4K241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc.20241—
+4K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc.20241—
+4K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+4K233360Curiteva Thoracolumbar Plate SystemCuriteva, Inc.20240—
+4K231715MONDRIAN™ Anterior Lumbar Plate SystemCtl Medical Corporation20240—
+4K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+4K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+4K232123MectaLIF Anterior Lag ExtensionMedacta International S.A.20231—
+4K231739Cervical Spine Truss System (CSTS)4Web Medical, Inc.20232—
+4K222988neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D CervicalHt Medical D.B.A. Xenix Medical20232—
+4K230731Zavation ALIF SystemZavation Medical Products, LLC20232—