510(k) Report

Devices descending from K062407

127 later devices reach Gateway Thoracolumbar Plate System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K100061Cayman Screws Model K2-12-1000-XX, K2-12-1001-XXK2m, Inc.201073—
+1K092108Truss Thoracolumbar Plate SystemGlobus Medical, Inc.200942—
+1K062836Citadel Anterior Lumbar Plate SystemGlobus Medical, Inc.200650—
+2K232318VICTORY™ Lumbar Plate SystemGlobus Medical, Inc.20230—
+2K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+2K213820BALTEUM - ONE™ Lumbar Plate SystemHuvexel Co., Ltd.20223—
+2K181846ASSURE Anterior Cervical Plate System, PROVIDENCE Anterior Cervical Plate System, VIP…Globus Medical, Inc.20184—
+2K142699LITe Plate SystemStryker Corporation201446—
+2K131533Cayman MI Plate SystemK2m, Inc.201372—
+2K120092Plymouth Thoracolumbar Plate SystemGlobus Medical, Inc.201241—
+3K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+3K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+3K233360Curiteva Thoracolumbar Plate SystemCuriteva, Inc.20240—
+3K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+3K223719Paeon Anterior Cervical Plate System, Elatus Lumbar Plate SystemAegis Spine, Inc.20233—
+3K222572FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, and…Dio Medical Corporation20222—
+3K192481AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd.202013—
+3K200846Balteum™ Lumbar Plate SystemHuvexel Co., Ltd.20204—
+3K191584FORTICO Anterior Cervical Fixation SystemCamber Spine Technologies, LLC20192—
+3K190016Lateral Plate SystemCorelink, LLC201915—
+3K190584CAYMAN LP Plate SystemK2m, Inc.20192—
+3K183214Raven Lumbar Plate SystemChoicespine, LP20192—
+3K182473PYRENEES Cervical Plate System, BLUE RIDGE Cervical Plate System, OZARK Cervical Plate…K2m, Inc.20184—
+3K173885Genesys Spine Binary Lumbar Plate SystemGenesys Spine20184—
+3K172941CASCADIA Interbody SystemK2m201852—
+3K1721312 Hole Lateral Plating SystemLife Spine, Inc.201710—
+3K150449LITe Plate SystemStryker Corp.201524—
+3K140260Skyhawk Lateral Plate SystemOrthofix, Inc.201414—
+4K260015ANTERIS Thoracolumbar Plate SystemSpineCraft20260—
+4K251940PathLoc Lumbar Plate SystemL&K BIOMED Co., Ltd.20260—
+4K253545Vulcan Spinal SystemK2m, Inc.20260—
+4K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+4K250446Frida™ Anterior Cervical Plate SystemSpineup, Inc.20250—
+4K241175MiRus MoRe Lumbar Plating SystemMiRus, LLC20240—
+4K231715MONDRIAN™ Anterior Lumbar Plate SystemCtl Medical Corporation20240—
+4K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+4K232154MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate FixationMiRus, LLC20230—
+4K231839CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd.20232—
+4K231460FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System…K&J Consulting Corp.20230—
+4K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+4K222806Kodiak C Spinal Implant SystemMet One Technologies, LLC20221—
+4K220843OAKTREE Anterior Lumbar Plate and Screw SystemOak Tree Engineering, LLC20220—
+4K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc.20221—
+4K221728Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran™ Anterior…Stryker Corporation20221—
+4K220324AccuFit Lateral 2-Hole PlatePrecision Spine, Inc.20223—
+4K211205Prase-C Anterior Cervical Plate SystemGbs Commonwealth Co., Ltd.20210—
+4K211932Fixxsure Anterior Lumbar Plate and Screw SystemOak Tree Engineering, LLC20211—
+4K203065Lumbar Spine Truss System Plating Solution (LSTS-PS)4Web, Inc.20219—
+4K210035ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix…Aegis Spine202110—
+4K202192STRUXXURE®-L and STRUXXURE®-A Plate SystemNexxt Spine, LLC20200—
+4K192678Genesys Spine Binary® Lumbar Plate SystemGenesys Spine20191—
+4K191354Ti3Z Cervical Interbody SystemZavation Medical Products, LLC201913—
+4K182210TiWAVE-L Porous Titanium Lumbar CageKalitec Medical, LLC20193—
+4K181347Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC201824—
+4K180166Life Spine Lumbar Fixation System (SENTRY)Life Spine, Inc.20189—
+4K160362Z-Span Plate SystemZavation, LLC20163—
+5K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+5K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.20260—
+5K260340HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC…HC Biologics, LLC20260—
+5K253201Lumbar Spine Truss System - Plating Solution (LSTS-PS)4Web, Inc.20260—
+5K252711Advantage-C™ Ti3D Cervical Interbody Fusion DeviceIntelivation Technologies20260—
+5K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc.20250—
+5K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc.20250—
+5K241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc.20241—
+5K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc.20241—
+5K231739Cervical Spine Truss System (CSTS)4Web Medical, Inc.20232—
+5K222988neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D CervicalHt Medical D.B.A. Xenix Medical20232—
+5K231840CastleLoc-S Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd.20230—
+5K231841PathLoc SI Joint Fusion SystemL&K BIOMED Co., Ltd.20231—
+5K230851Kodiak Lumbar Spacer SystemMet One Technologies, LLC20230—
+5K230424Omnia Medical Coupler-A™ Anterior Lumbar Plate System; Omnia Medical Coupler-L™ Lateral…Omnia Medical, LLC20230—
+5K223362Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device4Web Medical, Inc.20233—
+5K223521ZESPIN SI Joint Fusion SystemAegis Spine, Inc.20232—
+5K222628Life Spine ALIF Buttress Plate SystemLife Spine, Inc.20220—
+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—
+5K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+5K211474Kleiner KG2 SystemBAAT Medical Products B.V.20210—
+5K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+5K202624Z-Span Plate SystemZavation Medical Products, LLC20201—
+5K202305Zavation IBF SystemZavation Medical Products, LLC20209—
+5K200956NuVasive Thoracolumbar PlatesNu Vasive, Incorporated20200—
+5K200338ProLift Lateral FixatedLife Spine, Inc.20205—
+5K182987Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20199—
+5K162824Z-Span Plate SystemZavation, LLC20172—
+6K261810Vertiwedge® Intraosseous SystemFoundation Surgical Group20260—
+6K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+6K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine20260—
+6K253583LUX Expandable Lumbar Interbody SystemXenix Medical20260—
+6K253748Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer SystemLife Spine, Inc.20260—
+6K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+6K251117Cervical Spine Truss System (CSTS)4Web Medical20250—
+6K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+6K233966Anterior Spine Truss System-Stand Alone (ASTS-SA)4Web Medical, Inc.20241—
+6K240201PathLoc SI Joint Fusion SystemL&K BIOMED Co., Ltd.20240—
+6K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+6K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+6K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+6K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC20223—
+6K220096Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20220—