510(k) Report

Devices descending from K841189

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K191722Vital Navigation SystemZimmer Biomet Spine, Inc.20192—
+7K192582NuVasive CoRoent Small Interlock SystemNu Vasive, Incorporated201930—
+7K192168Idys ALIF ZP 3DTiClariance, Sas20195—
+7K191584FORTICO Anterior Cervical Fixation SystemCamber Spine Technologies, LLC20192—
+7K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+7K190526High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsCarboFix Orthopedics, Ltd.201928—
+7K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc.20196—
+7K182608Oyster ACIF CageSilony Medical GmbH20190—
+7K191263Idys ALIF TiVacClariance, Sas20190—
+7K191091Rampart One Lumbar Interbody Fusion SystemSpineology, Inc.20191—
+7K183639Mariner Outrigger Revision SystemSeaSpine Orthopedics Corporation20198—
+7K190655SeaSpine® Shoreline™ ACS- Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation201974—
+7K190361Zavation Spinal SystemZavation Medical Products, LLC20190—
+7K182771ISS-JAZZ Screw System and JAZZ CAP SPImplanet, S.A.20195—
+7K173518Spectrum Spine Expandable Cages (SSEC)Spectrum Spine, LLC20196—
+7K190055Duo Lumbar Interbody Fusion DeviceSpineology, Inc.20191—
+7K183397ChoiceSpine Stealth Cervical Spacer SystemChoicespine, LP201916—
+7K182406Altus Spine Interbody Fusion SystemAltus Partners, LLC20191—
+7K190067Velofix Interbody Fusion SystemU&I Corporation20193—
+7K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—
+7K182478Whistler Modular Pedicle Screw SystemEvolution Spine, LLC20196—
+7K180228II-Type Intervertebral SpacerPaonan Biotech Co., Ltd.20191—
+7K182954Salvo™ Spine SystemSpine Wave, Inc.20186—
+7K183080Mega Plus Spine SystemBk Meditech, Co., Ltd.20182—
+7K182007Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies20180—
+7K181829Velofix TLIF CageU&I Corporation20181—
+7K180980ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization SystemCamber Spine Technologies, LLC20181—
+7K182239OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20182—
+7K182240PASS LP Spinal SystemMedicrea International SA20182—
+7K181644EIT Cellular Titanium® Lumbar Cage LLIFEit Emerging Implant Technologies GmbH2018141—
+7K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+7K182377CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.201839—
+7K182345Spineology Navigation InstrumentsSpineology, Inc.20182—
+7K180179Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird®…Orthofix, Inc.201837—
+7K180777K2M Expandable Interbody SystemK2m, Inc.20180—
+7K181453ATEC ALIF Spacer SystemAlphatec Spine, Inc.2018111—
+7K181350ASTRA-OCT Spine SystemSpinecraft, LLC20180—
+7K180038NuVasive Pulse SystemNu Vasive, Incorporated20183—
+7K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+7K180796Spineology Navigation InstrumentsSpineology, Inc.20183—
+7K180433Ennovate®Aesculap Implant Systems, LLC201811
+7K173472MySpine Pedicle Screw Placement Guides – MC and Drill Pilot InstrumentsMedacta International S.A.20185—
+7K180376K2M Patient Specific RodsK2m, Inc.20182—
+7K180475CapLOX II® / TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20180—
+7K180198NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated20184—
+7K171495Zyston Strut Open Titanium Spacer SystemZimmer Biomet Spine, Inc.20181—
+7K173102Reliance Cervical IBF SystemReliance Medical Systems, LLC201715—
+7K171434ROCCIA® MultiLIFSilony Medical GmbH20174—
+7K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc.201721—
+7K173153Vertera Spine™ Coalesce™ Thoracolumbar Interbody Fusion SystemNu Vasive, Incorporated2017160—
+7K170553Altus Spine Interbody Fusion SystemAltus Partners, LLC20170—
+7K172253Altus Spine Cervical Interbody Fusion SystemAltus Partners, LLC20170—
+7K173095VIPER PRIME™ Screws, VIPER PRIME™ Screws with Fenestrations, EXPEDIUM® Verse Screws with…Medos International SARL201719—
+7K171489Acapella Cervical Spacer SystemChoicespine, LP201739—
+7K172724XIA® 4.5 Spinal System, Power Adaptor Instrument AccessoryStryker Corporation20179—
+7K171894NuVasive® Precept™ Spinal SystemNu Vasive, Incorporated20170—
+7K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart20179—
+7K172489Reliance Cervical IBF SystemReliance Medical Systems, LLC201716—
+7K171329Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC20172—
+7K171651Excelsius GPSGlobus Medical, Inc.2017691
+7K170861PremierShandong Weigao Orthopaedic Device Co., Ltd.20170—
+7K171369M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20178—
+7K171630LumFuse-TPPrecifit Medical, Ltd.20171—
+7K171425Concorde LiftMedos International SARL201782
+7K171907Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc.2017162
+7K170962NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated2017304—
+7K170395Talos® Lumbar (HA) PEEK IBF DevicesMeditech Spine, LLC201710—
+7K171438Palisade™ Pedicular Fixation SystemSpineology, Inc.20171—
+7K170496Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument AccessoryStryker Corporation2017151
+7K171097MOJAVE Expandable Interbody SystemK2m, Inc.201717—
+7K170543VIPER PRIME™ Screws with FenestrationsMedos International SARL201748—
+7K162266The Cranial Fusion SystemLife Spine, Inc.20171—
+7K163491NuVasive CoRoent Small Interbody SystemNu Vasive, Incorporated2017289—
+7K170512Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC20176—
+7K163604SeaSpine® Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation201712—
+7K162760Spine Wave Anterior Cervical Spine SystemSpine Wave, Inc.20171—
+7K162587Roccia® AcifSilony Medical GmbH20171—
+7K162764Jazz Frame SystemImplanet, S.A.20176—
+7K161032neon3™ universal OCT spinal stabilizationUlrich GmbH & Co. KG201671
+7K162262Tritanium® PL CageStryker2016132—
+7K162944Irix-C Cervical Integrated Fusion SystemX-Spine Systems, Inc.20161—
+7K161642CAVUX™ Cervical CageProvidence Medical Technology, Inc.20160—
+7K161081SeaSpine Shoreline ACS - Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation201683—
+7K161888JULIET® LL Lateral Lumbar CageSpineart2016145—
+7K160465Spinal Elements' Spinous Process Plate SystemSpinal Elements, Inc.20160—
+7K161369EVEREST Spinal SystemK2m, Incorporated20169—
+7K160955Tritanium® PL CageStryker2016178—
+7K160906Rampart O Lumbar Interbody Fusion Device, Rampart T Lumbar Interbody Fusion Device…Spineology, Inc.201627—
+7K152622Alta ACDF SystemBiomet Spine20160—
+7K153273MySpine Pedicle Screw Placement Guides - LPMedacta International S.A.20166—
+7K160926F1 MPS Modular Pedicle Screw SystemDegen Medical20161—
+7K152011Lucent Intervertebral Body Fusion DeviceSpinal Elements, Inc.2016106—
+7K160980Threshold Pedicular Fixation System, Palisade Pedicular Fixation SystemSpineology, Inc.20166—
+7K160226JAZZ CLAW System (hooks and rods) and JAZZ CLAW connectorImplanet, S.A.20161—
+7K152539SpineView X-Pac Expandable Lumbar Cage SystemSpine View, Inc.20166—
+7K153428Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2016731
+7K153525Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine20160—
+7K153695Biomet Spine Fusion SystemBiomet Spine, LLC201632
+7K153463CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc.201587—
+7K152651AccuLIF TL and PL CageStryker Corporation201530—