510(k) Report

Devices descending from K033312

277 later devices reach Ebi Top Loading Mas Spinal Fixation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K110321Tiger Spine SystemCorelink, LLC201183—
+1K090523Polaris Spinal SystemEbi, L.P.2009156—
+1K082187Biomet Anterior Lumbar PlateEbi, L.P.2008126—
+1K062685Ebi Aray Spinal SystemEbi, L.P.2006281
+1K042772Ebi Array Spinal Fixation System and Spinelink II Spinal Fixation DeviceEbi, L.P.20043—
+2K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+2K190016Lateral Plate SystemCorelink, LLC201915—
+2K141291Vertiform Posterior Fixation SystemNext Orthosurgical20142—
+2K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2014671
+2K133369Tiger Spine SystemCorelink, LLC201429—
+2K131250Tiger Spine SystemCorelink, LLC201340—
+2K121791Zou Anterior Lumbar Plate SystemCorelink, LLC2012113—
+2K121786Dymaxeon Spine SystemB2b Spine Pty, Ltd.20125—
+2K120696Tiger Spine SystemCorelink, LLC201241—
+2K113058Tiger Spine SystemCorelink, LLC201281—
+2K103393Polaris Spinal SystemBiomet Spine2011104—
+2K100409Polaris Spinal System, Polaris/Synergy Structue Anterior Fixation SystemBiomet Spine (Aka Ebi, LLC)2010144—
+2K100438Polaris Spinal System, Polaris/Synergy Structure Anterior Fixation SystemEbi, L.P.2010104—
+2K100220Polaris Spinal SystemEbi, L.P.2010153—
+2K090320Conquest Spinal SystemLife Spine20092—
+2K073430Valeo Pedicle Screw Spinal SystemAmedica Corp.200824—
+2K070530Modification to Passmed Spinal SystemMedicrea Technologies20072—
+3K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+3K242900VADER® Pedicle System and VADER®one Pedicle SystemIcotec AG20250—
+3K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+3K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+3K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+3K220025ARx® Spinal SystemLife Spine, Inc.20220—
+3K203065Lumbar Spine Truss System Plating Solution (LSTS-PS)4Web, Inc.20219—
+3K200596G21 Cement, VADER® Pedicle SystemIcotec AG2020271
+3K202192STRUXXURE®-L and STRUXXURE®-A Plate SystemNexxt Spine, LLC20200—
+3K193423VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG202061
+3K193211Nano FortiFix® SystemNanovis Spine, LLC20201—
+3K190981NEX-D2 Posterior Fixation SystemNext Orthosurgical20200—
+3K193219G Surgical Marksman SystemG Surgical, LLC20191—
+3K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+3K190545VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG2019291
+3K190376PASS LP Spinal SystemMedicrea International SA201915
+3K183214Raven Lumbar Plate SystemChoicespine, LP20192—
+3K182746ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc.2018110—
+3K170989Dymaxeon Spine SystemBack 2 Basics Direct, LLC20172—
+3K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+3K162160Preference Elite Pedicle Screw SystemAmedica Corporation20161—
+3K161499VertiForm Posterior Fixation SystemNext Orthosurgical20161—
+3K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+3K151977icotec Pedicle SystemIcotec AG201630—
+3K151770Libra Pedicle Screw SystemSpinal Balance, Inc.20151—
+3K151974Polaris Spinal SystemBiomet Spine201516—
+3K151648Altus Spine Pedicle Screw System, Altus Spine MIS Pedicle Screw System, Valencia Pedicle…Altus Partners, LLC20155—
+3K150896Vitality Spinal Fixation SystemZimmer Spine, Inc.2015193
+3K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+3K150184Dymaxeon Spine SystemBack 2 Basics Direct, LLC201541
+3K143248Reform Pedicle Screw SystemPrecision Spine, Inc.201430—
+3K142146Ibis Pedicle Screw SystemOrtho Development Corp.20145—
+3K133743Baxano Surgical Mis Spinal SystemBaxano Surgical, Inc.20140—
+3K131785Pagoda Pedicle Screw SystemOrtho Development Corp.20136—
+3K111957Polaris Spinal SystemBiomet Spine (Ebi, LLC)201176—
+3K110906Apex Spine SystemSpinecraft, LLC2011103—
+3K080767Conquest Spinal SystemLife Spine200821—
+4K260015ANTERIS Thoracolumbar Plate SystemSpineCraft20260—
+4K253201Lumbar Spine Truss System - Plating Solution (LSTS-PS)4Web, Inc.20260—
+4K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc.20250—
+4K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+4K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+4K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+4K230325GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal SystemGreens Surgicals Pvt., Ltd.20240—
+4K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+4K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc.20241—
+4K242069Eminent Spine Scoliosis Deformity Pedicle Screw SystemEminent Spine20240—
+4K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+4K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+4K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+4K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+4K231739Cervical Spine Truss System (CSTS)4Web Medical, Inc.20232—
+4K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+4K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+4K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+4K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+4K230063G Surgical Marksman Spinal Deformity SystemG Surgical, LLC20230—
+4K223362Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device4Web Medical, Inc.20233—
+4K222789VADER® Pedicle System, G21 CementIcotec AG202352
+4K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+4K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+4K221332OsteoCentric Spine MIS Pedicle Fastener SystemOsteoCentric Technologies20221—
+4K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+4K212527Cervical Spine Truss System Plating Solution (CSTS-PS)4Web Medical, Inc.20220—
+4K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+4K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+4K212185Golden Isles Pedicle Screw SystemIntelivation, LLC20210—
+4K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+4K203023Pisces Spinal SystemOrtho Development Corporation20210—
+4K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+4K210275Polaris Spinal SystemZimmer Biomet Spine, Inc.20210—
+4K202495SIRION Lateral Lumbar Interbody FusionAstura Medical, LLC20216—
+4K203452Nano FortiFix® SystemNanovis, LLC20200—
+4K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+4K200303Reform Pedicle Screw SystemPrecision Spine202010—
+4K192930Dymaxeon Spine SystemBack 2 Basics Direct, LLC20201—
+4K192006SIRION Lateral Lumbar Interbody SystemAstura Medical, LLC202014—
+4K193396PERLA® TL posterior osteosynthesis systemSpineart202072