510(k) Report

Devices descending from K841189

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K232116CoreLink Navigation InstrumentsCorelink, LLC20230—
+7K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+7K231636LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20232—
+7K230861VADER® Pedicle System Navigated InstrumentsIcotec AG20230—
+7K223143SAGICO Spinal SystemSagico VA USA, LLC20230—
+7K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+7K223096Dark Star Deformity Pedicle Screw SystemRepublic Spine, LLC20231—
+7K222833Ventana™ C Spinal SystemSpinal Elements, Inc.20234—
+7K231140aprevo® transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20236—
+7K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+7K222004INTEGRATE -C Interbody Fusion SystemHappe Spine20236—
+7K223868PYXIS 3D Titanium Cage SystemGS Medical Co., Ltd.20232—
+7K220261NEST-C Interbody SystemPaonan Biotech Co., Ltd.20230—
+7K230766Altus Spine Monaco Pedicle Screw SystemAltus Spine20231—
+7K221324ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF)Camber Spine Technologies20230—
+7K223326Axiom PSR SystemRestor3D202301
+7K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+7K223418DeGen Impulse AM™ SystemDegen Medical20236—
+7K223776PEEK Spinal Infusion CageChangzhou Geasure Medical Apparatus and Instruments Co., Ltd.20230—
+7K230245LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20233—
+7K223231Ti-Largo Cervical Interbody SystemFlospine20230—
+7K223764INFINITY OCT SystemMedtronic Sofamor Danek USA, Inc.20230—
+7K223273ASTRA Spine SystemSpinecraft, LLC20228—
+7K223140AEON-C™ Stand Alone SystemDio Medical, Inc.20222—
+7K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+7K212612Omnia Medical TiBrid-SCOmnia Medical, LLC20220—
+7K220334MONET Anterior Cervical Plate SystemCtl Medical Corporation20220—
+7K221936Standalone ALIF Interbody Fusion SystemEminent Spine20222—
+7K222276CONDUIT Cages; FIBERGRAFT BG PuttyDepuy Spine202229—
+7K222473EXPEDIUM® Spine System, EXPEDIUM VERSE® Spine System: ALTALYNE™ Ultra RodsMedos-International Sarl20221—
+7K211027Altus Spine Pedicle Screw SystemAltus Partners, LLC20222—
+7K213641MONDRIAN ALIF Cage with Supplementary Fixation PlateCtl Medical Corporation20221—
+7K221745Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co, Ltd.20220—
+7K222256BonOs® Inject Bone Cement; NEO Pedicle Screw System™Neo Medical SA20223—
+7K221325CONDUIT Lateral Switch PlateMedos International SARL20221—
+7K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+7K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+7K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+7K221687Pegasus-X Expandable PLIF SystemGS Medical Co., Ltd.20220—
+7K220581Zavation eZspand Interbody SystemZavation Medical Products, LLC20224—
+7K213420WaveForm L System, WaveForm TO System, WaveForm TA SystemSeaSpine Orthopedics Corporation202211—
+7K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+7K212477EARP Interbody SystemNvision Biomedical Technologies, Inc.20221—
+7K220810Infinity™ OCT System and PASS OCT Spinal SystemMedicrea International20220—
+7K220131KYPHON VuE Bone CementTecres S.P.A.20220—
+7K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+7K220025ARx® Spinal SystemLife Spine, Inc.20220—
+7K220374EXPEDIUM VERSE® Fenestrated Screw System (Sterile Fenestrated Screws)Medos International SARL20229—
+7K212930LumiVy Lumbar IBF SystemVy Spine, LLC20226—
+7K213918DeGen Navigated InstrumentationDegen Medical20220—
+7K214059CoreLink Navigation InstrumentsCorelink, LLC20220—
+7K212967AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.20211—
+7K201793EDEN Peek CageJmt Co., Ltd.20210—
+7K211449Triton™ Sacroiliac Joint Fixation SystemChoice Spine, LLC20211—
+7K212070KMTI S141 Lumbar Interbody Fusion SystemKyocera Medical Technologies, Inc.20210—
+7K211903Shoreline Threaded TruProfile® PlateSeaSpine Orthopedics Corporation20217—
+7K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+7K210800IO Expandable Lumbar Interbody Fusion SystemMiRus, LLC20212—
+7K211957QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.20213—
+7K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+7K211306LabyrinthZavation Medical Products, LLC20213—
+7K211441Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.20219—
+7K210549ARx Spinal SystemLife Spine, Inc.20211—
+7K200919Idys ALIF 3DTiClariance20210—
+7K210275Polaris Spinal SystemZimmer Biomet Spine, Inc.20210—
+7K210449Infinity™ OCT System, PASS OCT® Spinal SystemMedtronic20213—
+7K203342CONSTRUX Mini Ti Spacer SystemOrthofix, Inc.202191
+7K203576FORZA Ti Spacer SystemOrthofix, Inc.202161
+7K202298Lucent XP, Lucent XP CurvedSpinal Elements, Inc.20202—
+7K203452Nano FortiFix® SystemNanovis, LLC20200—
+7K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+7K200719NuVasive Navigation.S InstrumentsNu Vasive, Incorporated20204—
+7K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+7K200316UNiD IB3D ALIFMedicrea International SA20200—
+7K202949CONSTRUX Mini PEEK Spacer SystemOrthofix, Inc.20206—
+7K200937ACURA Stabilization SystemIndius Medical Technologies Pvt., Ltd.20200—
+7K202528Cannulated Power Driver AttachmentK2m, Inc.20200—
+7K200084Zavation IBF SystemZavation Medical Products, LLC20208—
+7K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+7K202666CONSTRUX Mini PTC Spacer SystemOrthofix, Inc.202010—
+7K201831CONFIDENCE Spinal Cement SystemDepuy Spine, Inc.20200—
+7K201605EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF Cage, EIT Cellular…Eit Emerging Implant Technologies GmbH2020130—
+7K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+7K193172Luna XD Ti Interbody Fusion SystemBenvenue Medical, Inc.20201—
+7K200322Altus Spine Pedicle Screw SystemAltus Partners, LLC20204—
+7K200920Idys ALIF ZP 3DTiClariance, Sas20203—
+7K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+7K200303Reform Pedicle Screw SystemPrecision Spine202010—
+7K200991EVOL Spinal Interbody SystemCutting Edge Spine, LLC20200—
+7K200666Stryker Xia 3 Power AdaptorStryker Spine20203—
+7K192646SYMPHONY™ OCT SystemMedos International SARL20202—
+7K192818Vertaplex HV High Viscosity Radiopaque Bone Cement; ES2 Augmentable Spinal SystemStryker Corporation20208—
+7K193211Nano FortiFix® SystemNanovis Spine, LLC20201—
+7K200381Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation20202—
+7K193255Largo PEEK Interbody SystemFlospine, LLC20201—
+7K193203MOJAVE Expandable Interbody SystemK2m, Inc.202015—
+7K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+7K193270CapLOX II®/TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20200—
+7K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20206—
+7K193219G Surgical Marksman SystemG Surgical, LLC20191—