510(k) Report

Devices descending from K994122

251 later devices reach Bone Graft Washer, Model 9090114 - 9090118 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K073349Reliance Buttress Washer SystemReliance Medical Systems, LLC20081—
+1K013665Pyramid Anterior Plate Fixation SystemMedtronic Sofamor Danek, Inc.2002248—
+2K213219Vy Spine™ VyWasher™ Buttress SystemVy Spine, LLC20210—
+2K192492EL CAPITAN Anterior Lumber Interbody SystemAstura Medical, LLC202010—
+2K163625NOOSA Anterior Lumbar Plate System;NAMBUCCA Anterior Lumbar Plate System; CAIRNS…Signature Orthopaedics Pty, Ltd.20172—
+2K124034Mectalif AnteriorMedacta International201311—
+2K091253Thoracolumbar Plate, Model 1208-41FXX, Lumber Plate, Model 1208-41FXXL, Sacral Plate…K2m, Inc.200973—
+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—
+2K021226Modification to Pyramid Anterior Plate Fixation SystemMedtronic Sofamor Danek20020—
+3K254202MectaLIF 3D Metal AnteriorMedacta International S.A.20260—
+3K232318VICTORY™ Lumbar Plate SystemGlobus Medical, Inc.20230—
+3K222554EL CAPITAN Anterior Lumbar Interbody FusionAstura Medical20235—
+3K221545MectaLIF Anterior ExtensionMedacta International S.A.202226
+3K214047EL CAPITAN Anterior Lumbar Interbody Fusion SystemAstura Medical20223—
+3K212937Dakota ALIF Plate SystemPrecision Spine, Inc.20210—
+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—
+3K181190Pinehurst Anterior Cervical Plate SystemSignature Orthopaedics Pty, Ltd.20190—
+3K181846ASSURE Anterior Cervical Plate System, PROVIDENCE Anterior Cervical Plate System, VIP…Globus Medical, Inc.20184—
+3K173885Genesys Spine Binary Lumbar Plate SystemGenesys Spine20184—
+3K172019Brisbane ALIF Device, Gladstone ALIF DeviceSignature Orthopaedics Pty, Ltd.20170—
+3K162211AccuFit Lateral Plate SystemPrecision Spine, Inc.20164—
+3K160605MectaLIF Anterior Stand-AloneMedacta International201610—
+3K142699LITe Plate SystemStryker Corporation201446—
+3K131533Cayman MI Plate SystemK2m, Inc.201372—
+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—
+3K101255Alphatec Spine Anterior Lumbar Plating SystemAlphatec Spine, Inc.2010113—
+3K092765Lanx Anterior Plating SystemLanx, Inc.20101—
+3K091044Spinal Usa Anterior Lumbar Plate SystemSpinal USA2009159—
+3K072231The Translation Plate Phase 1 (T-1 Plate) and Phase 2 (T-2 Plate)Esm Technologies, LLC20070—
+3K061229Unity LX Anterolateral Lumbar Plate Fixation SystemBlackstone Medical, Inc.2006165—
+4K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+4K260015ANTERIS Thoracolumbar Plate SystemSpineCraft20260—
+4K251940PathLoc Lumbar Plate SystemL&K BIOMED Co., Ltd.20260—
+4K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+4K250603AxTiHA® Stand-Alone ALIF SystemInnovasis20250—
+4K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+4K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+4K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+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—
+4K230731Zavation ALIF SystemZavation Medical Products, LLC20232—
+4K223719Paeon Anterior Cervical Plate System, Elatus Lumbar Plate SystemAegis Spine, Inc.20233—
+4K220324AccuFit Lateral 2-Hole PlatePrecision Spine, Inc.20223—
+4K2117123° Anterior Cervical Plating System, Reliant Anterior Cervical Plating System, Unity…Orthofix US, LLC20220—
+4K203076Mecta-C Stand Alone ExtensionMedacta International S.A.20200—
+4K202309Epic Anterior Thoracolumbar Plate System, Gallery Laminoplasty Fixation System, Concero…Zimmer Biomet Spine, Inc.20200—
+4K192481AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd.202013—
+4K192678Genesys Spine Binary® Lumbar Plate SystemGenesys Spine20191—
+4K191584FORTICO Anterior Cervical Fixation SystemCamber Spine Technologies, LLC20192—
+4K190016Lateral Plate SystemCorelink, LLC201915—
+4K190584CAYMAN LP Plate SystemK2m, Inc.20192—
+4K183426MectaLIF Anterior Stand Alone ExtensionMedacta International S.A.20191—
+4K183214Raven Lumbar Plate SystemChoicespine, LP20192—
+4K182473PYRENEES Cervical Plate System, BLUE RIDGE Cervical Plate System, OZARK Cervical Plate…K2m, Inc.20184—
+4K182746ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc.2018110—
+4K182808Aspida® Anterior Lumbar Plating SystemAlphatec Spine, Inc.20181—
+4K180166Life Spine Lumbar Fixation System (SENTRY)Life Spine, Inc.20189—
+4K172941CASCADIA Interbody SystemK2m201852—
+4K1721312 Hole Lateral Plating SystemLife Spine, Inc.201710—
+4K170455MectaLIF Anterior Stand AloneMedacta International S.A.20174—
+4K150449LITe Plate SystemStryker Corp.201524—
+4K130868Nuvasive Decade Lateral Plate SystemNuvasive, Inc.201319—
+4K121837Nuvasive Brigade Anterior Plate SystemNuvasive, Inc.20123—
+5K253545Vulcan Spinal SystemK2m, Inc.20260—
+5K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+5K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+5K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+5K241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc.20241—
+5K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+5K241175MiRus MoRe Lumbar Plating SystemMiRus, LLC20240—
+5K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+5K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+5K232154MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate FixationMiRus, LLC20230—
+5K231839CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd.20232—
+5K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+5K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+5K222806Kodiak C Spinal Implant SystemMet One Technologies, LLC20221—
+5K220843OAKTREE Anterior Lumbar Plate and Screw SystemOak Tree Engineering, LLC20220—
+5K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc.20221—
+5K222628Life Spine ALIF Buttress Plate SystemLife Spine, Inc.20220—
+5K221728Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran™ Anterior…Stryker Corporation20221—
+5K221447Southern Anterior Screw Fixated Cage (SASCA)Southern Medical (Pty), Ltd.20220—
+5K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+5K220478NuVasive MOD-EX XLIF Interbody System, NuVasive MOD-EX XLIF Plated 2.0 Interbody SystemNu Vasive, Incorporated20222—
+5K211205Prase-C Anterior Cervical Plate SystemGbs Commonwealth Co., Ltd.20210—