510(k) Report

Devices descending from K841189

2,425 later devices reach Oec/Rezaian Spinal Fixator through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K230614Cortium™Ulrich Medical USA20230—
+8K230565HILINE™ Fixation SystemGlobus Medical, Inc.20230—
+8K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+8K223174X-Pac Expandable LLIF Cage SystemExpanding Innovations, Inc.20233—
+8K230063G Surgical Marksman Spinal Deformity SystemG Surgical, LLC20230—
+8K222614Zavation Spinal SystemZavation Medical Products, LLC20223—
+8K211785CASSATT™ SIJ Fixation SystemCtl Medical Corporation20220—
+8K213876Spineology Navigation InstrumentsSpineology, Inc.20221—
+8K221332OsteoCentric Spine MIS Pedicle Fastener SystemOsteoCentric Technologies20221—
+8K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+8K220449DePuy CONDUIT LLIF SQUID InserterEnztec Limited20220—
+8K220902Navagio Lumbar CageKalitec Medical, LLC20220—
+8K220570M.U.S.T. MINI Posterior Cervical Screws System ExtensionMedacta International S.A.20220—
+8K213654NuVasive Reline Cervical SystemNu Vasive, Incorporated20221—
+8K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+8K212715Vy Spine ClariVy Cervical IBF SystemVy Spine, LLC20216—
+8K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+8K212823DePuy CONDUIT LLIF Angled InsertersEnztec Limited20213—
+8K211205Prase-C Anterior Cervical Plate SystemGbs Commonwealth Co., Ltd.20210—
+8K211993Z-LINKPC SystemZavation Medical Products, LLC20210—
+8K211710Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal…Orthofix, Inc.20212—
+8K210574NuVasive Pulse SystemNu Vasive, Incorporated202121
+8K211113Zavation Spinal SystemZavation Medical Products, LLC20214—
+8K211442StealthStation Spinous Process ClampsMedtronic Navigation20212—
+8K211238SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone…Stryker Instruments20212—
+8K201569CUVIS-spineCurexo, Inc.20212—
+8K210728CONDUIT InstrumentsMedos International SARL20215—
+8K203673MySpine Pedicle Screw Placement Guides Extension (MySpine Low Profile Guides, MySpine MC…Medacta International S.A.20213—
+8K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+8K203319SYMPHONY™ OCT SystemMedos International SARL20211—
+8K200922Altus Spine HA Pedicle Screw SystemAltus Partners, LLC20213—
+8K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+8K203149M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20200—
+8K200596G21 Cement, VADER® Pedicle SystemIcotec AG2020271
+8K200792MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement GuidesMedacta Inernational SA20204—
+8K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+8K201240Mariner Cap SystemSeaSpine Orthopedics Corporation20200—
+8K201227Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20205—
+8K193423VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG202061
+8K200571PERLA® Posterior Occipito-Cervico-Thoracic Fixation SystemSpineart20200—
+8K200896Solstice CCILife Spine, Inc.20200—
+8K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+8K200130M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20206—
+8K191553NuVaisve® Reline® Cervical SystemNu Vasive, Incorporated20192—
+8K191217Jazz PFImplanet, S.A.20190—
+8K191045Salvo™ Spine SystemSpine Wave, Inc.20195—
+8K190545VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG2019291
+8K182349Concorde LiftMedos International SARL20190—
+8K182837M.U.S.T. Mini ExtensionMedacta International S.A.20191—
+8K181625Life Spine Resolute™ Threaded Cage SystemLife Spine, Inc.20180—
+8K182182YUKON OCT Spinal SystemK2m20185—
+8K181014Tritanium PL CageStryker Spine2018137—
+8K181281Altus Spine Pedicle Screw SystemAltus Partners, LLC20181—
+8K181188EVEREST Spinal SystemK2m, Inc.20186—
+8K173537Concorde Lift™Medos International SARL20181—
+8K172828Double Medical Cage SystemDouble Medical Technology, Inc.20181—
+8K173030Vertera Spine Cohere Cervical Interbody Fusion DeviceNu Vasive, Incorporated201722—
+8K173175Paramount Anterior Cervical Cage SystemSpine Wave, Inc.20170—
+8K171570Additional VIPER PRIME™ screws with fenestrationsMedos International SARL201720—
+8K171444YUKON OCT Spinal SystemK2m, Inc.2017133
+8K171881JAZZ Passer BandImplanet, S.A.20170—
+8K171456Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine20170—
+8K170730JAZZ System, including JAZZ BandImplanet, S.A.20175—
+8K170647Connector SystemOrthofix, Inc.201718—
+8K171082Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline…Orthofix, Inc.2017611
+8K163409Rampart (TM) T Lumbar Interbody Fusion DeviceSpineology, Inc.20170—
+8K162575Z-LINKPC SystemZavation, LLC20173—
+8K163543Biomet Fusion SystemZimmer Biomet Spine, Inc.2017124—
+8K162419FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20167—
+8K160074Rampart D Lumbar Interbody Fusion DeviceSpineology, Inc.20165—
+8K160856SpineView X-Pac Expandable Lumbar Cage SystemSpine View, Inc.20165—
+8K160715AccuLIF TL and PL CageStryker Corporation20160—
+8K153517AnyPlus® Cervical PEEK Cage SystemGS Medical Co., Ltd.201612—
+8K153629ArcadiusXP C Spinal SystemAesculap Implant Systems, Inc.20167—
+8K153783SpaceVision® PLIF, SpaceVision® OLIF, SpaceVision® TLIFSpinevision S.A.201613—
+8K160020Captiva Spine and CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20160—
+8K150918PASS OCT Spinal SystemMedicrea International SA201513—
+8K150231Navigated Disc Prep Instruments and CAPSTONE TrialsMedtronic Sofamor Danek USA, Inc.2015242—
+8K150552ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMSGlobus Medical, Inc.2015961
+8K150954Elite L Expandable Lumbar Fusion SystemInnova Spinal Technologies, LLC20156—
+8K150254Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)201523
+8K141284Caspian Spinal SystemK2m, Inc.20140—
+8K141217Acculif TL and PL CageStryker Corporation20146423
+8K140007Abacus TM Spacer SystemSpine Wave, Inc.20144—
+8K133374Streamline Oct Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Rti Surgical, I20143—
+8K131833Centurion Poct SystemOrthofix, Inc.20142—
+8K132719Staxx Ibl SystemSpine Wave, Inc.20137—
+8K122957Tezo Titanium Cage FamilyUlrich GmbH & Co. KG20130—
+8K121725Pioneer Posterior Occipito-Cervico-Thoracic (Oct) SystemPioneer Surgical Technology, Inc.201217—
+8K112700Frontier Sadl Interbody Fusion DeviceFrontier Medical Devices, Inc.20121—
+8K122085Stingray Cervical CageOmni Surgical, LP Dba Spine36020120—
+8K120998Solstice Cross ConnectorLife Spine20121—
+8K121892Phantom Plus Ceramic Cage SystemAmedica Corp.20127—
+8K120991TRANS1 Interbody Fusion SystemTrans1 Incorporated2012172—
+8K112405Clydesdales Spinal SystemMedtronic Sofamor Danek USA, Inc.2011296—
+8K110063Sovereign Spinal SystemMedtronic Sofamor Danek, Inc.2011718—
+8K103655Octane-C Interbody Fusion Device SystemExactech, Inc.2011481
+9K260369Dynamis Robotic Surgical SystemLEM Surgical AG20260—
+9K260329Ion-C Navigation InstrumentsSurGenTec, LLC20261—
+9K261130AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20260—