510(k) Report

Devices descending from K061789

530 later devices reach Lateral Plate System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K140260Skyhawk Lateral Plate SystemOrthofix, Inc.201414—
+1K133194Diamond Rattlesnake SystemEminent Spine201417—
+1K121815Nuvasive Sage Lateral Plate SystemNuvasive, Inc.2012469—
+1K091071Nuvasive Lateral Plate SystemNuvasive, Inc.200974—
+2K213820BALTEUM - ONE™ Lumbar Plate SystemHuvexel Co., Ltd.20223—
+2K200846Balteum™ Lumbar Plate SystemHuvexel Co., Ltd.20204—
+2K1721312 Hole Lateral Plating SystemLife Spine, Inc.201710—
+2K162211AccuFit Lateral Plate SystemPrecision Spine, Inc.20164—
+2K153097Belvedere™ Lateral Plating SystemNeurostructures, Inc.20160—
+2K160362Z-Span Plate SystemZavation, LLC20163—
+2K142699LITe Plate SystemStryker Corporation201446—
+2K131723Coroent Single Tab SystemNuvasive, Inc.2013466—
+2K130868Nuvasive Decade Lateral Plate SystemNuvasive, Inc.201319—
+2K120092Plymouth Thoracolumbar Plate SystemGlobus Medical, Inc.201241—
+3K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+3K233360Curiteva Thoracolumbar Plate SystemCuriteva, Inc.20240—
+3K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+3K232318VICTORY™ Lumbar Plate SystemGlobus Medical, Inc.20230—
+3K223719Paeon Anterior Cervical Plate System, Elatus Lumbar Plate SystemAegis Spine, Inc.20233—
+3K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc.20221—
+3K222572FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, and…Dio Medical Corporation20222—
+3K220478NuVasive MOD-EX XLIF Interbody System, NuVasive MOD-EX XLIF Plated 2.0 Interbody SystemNu Vasive, Incorporated20222—
+3K220324AccuFit Lateral 2-Hole PlatePrecision Spine, Inc.20223—
+3K202624Z-Span Plate SystemZavation Medical Products, LLC20201—
+3K192481AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd.202013—
+3K200956NuVasive Thoracolumbar PlatesNu Vasive, Incorporated20200—
+3K192006SIRION Lateral Lumbar Interbody SystemAstura Medical, LLC202014—
+3K190016Lateral Plate SystemCorelink, LLC201915—
+3K190584CAYMAN LP Plate SystemK2m, Inc.20192—
+3K183214Raven Lumbar Plate SystemChoicespine, LP20192—
+3K181846ASSURE Anterior Cervical Plate System, PROVIDENCE Anterior Cervical Plate System, VIP…Globus Medical, Inc.20184—
+3K180166Life Spine Lumbar Fixation System (SENTRY)Life Spine, Inc.20189—
+3K173885Genesys Spine Binary Lumbar Plate SystemGenesys Spine20184—
+3K162824Z-Span Plate SystemZavation, LLC20172—
+3K160051NuVasive® Interfixated Interbody SystemNu Vasive, Incorporated2016396—
+3K153782NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated2016390—
+3K150449LITe Plate SystemStryker Corp.201524—
+3K140479Coroent XL-F SystemNu Vasive, Incorporated2014465—
+4K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+4K260015ANTERIS Thoracolumbar Plate SystemSpineCraft20260—
+4K251940PathLoc Lumbar Plate SystemL&K BIOMED Co., Ltd.20260—
+4K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc.20250—
+4K250446Frida™ Anterior Cervical Plate SystemSpineup, Inc.20250—
+4K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+4K241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc.20241—
+4K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+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—
+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—
+4K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+4K223335SIRION Lateral Lumbar Interbody SystemAstura Medical20230—
+4K222554EL CAPITAN Anterior Lumbar Interbody FusionAstura Medical20235—
+4K220843OAKTREE Anterior Lumbar Plate and Screw SystemOak Tree Engineering, LLC20220—
+4K222628Life Spine ALIF Buttress Plate SystemLife Spine, Inc.20220—
+4K221728Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran™ Anterior…Stryker Corporation20221—
+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—
+4K202495SIRION Lateral Lumbar Interbody FusionAstura Medical, LLC20216—
+4K202192STRUXXURE®-L and STRUXXURE®-A Plate SystemNexxt Spine, LLC20200—
+4K200338ProLift Lateral FixatedLife Spine, Inc.20205—
+4K192497EVOL ha - D Lateral Interbody Fusion SystemCutting Edge Spine, LLC20201—
+4K192678Genesys Spine Binary® Lumbar Plate SystemGenesys Spine20191—
+4K191584FORTICO Anterior Cervical Fixation SystemCamber Spine Technologies, LLC20192—
+4K192760NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2019163—
+4K180519HARRIER-SA™ Lumbar Interbody SystemChoicespine, LP20180—
+4K170389TAURUS PEEK Cage SystemMedyssey USA, Inc.20170—
+4K172123NuVasive® Modulus XLIF Interbody SystemNu Vasive, Incorporated2017227—
+4K162358T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution SystemSynthes USA Products, LLC2016127—
+4K161379ELSA SpacersGlobus Medical, Inc.2016155—
+4K161230NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated2016381—
+4K161223TransContinental® M Spacers and InterContinental® Plate-SpacersGlobus Medical, Inc.2016117—
+4K160916CoRoent® Ti-C SystemNu Vasive, Incorporated2016139—
+4K151312VerteLP Interbody Fusion DeviceVgi, LLC201601
+4K143228Ancora LLC Interbody Fusion DeviceFrontier Medical Devices, Inc.20150—
+5K261810Vertiwedge® Intraosseous SystemFoundation Surgical Group20260—
+5K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+5K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.20260—
+5K253201Lumbar Spine Truss System - Plating Solution (LSTS-PS)4Web, Inc.20260—
+5K253545Vulcan Spinal SystemK2m, Inc.20260—
+5K253748Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer SystemLife Spine, Inc.20260—
+5K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc.20250—
+5K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+5K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+5K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc.20241—
+5K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+5K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+5K231739Cervical Spine Truss System (CSTS)4Web Medical, Inc.20232—
+5K231840CastleLoc-S Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd.20230—
+5K231841PathLoc SI Joint Fusion SystemL&K BIOMED Co., Ltd.20231—
+5K230424Omnia Medical Coupler-A™ Anterior Lumbar Plate System; Omnia Medical Coupler-L™ Lateral…Omnia Medical, LLC20230—
+5K223688CONDUIT™ Lateral Lumbar Intervertebral Fusion Cage, CONDUIT™ InstrumentsMedos International Sàrl20230—
+5K223362Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device4Web Medical, Inc.20233—
+5K223521ZESPIN SI Joint Fusion SystemAegis Spine, Inc.20232—
+5K2136534CIS Black Marlin Plif Cage System, 4CIS Dolphin Tlif Cage SystemSolco Biomedical Company India Private Limited20220—
+5K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—
+5K221325CONDUIT Lateral Switch PlateMedos International SARL20221—
+5K221050ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior…Aegis Spine, Inc.20226—