510(k) Report

Devices descending from K841189

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K223043The Integrity Spine Core SystemIntegrity Spine20230—
+5K222041CYGNUS-C Standalone ACIF SystemGS Medical Co., Ltd.20231—
+5K223146EVOLUTION SPINE Interbody SystemEvolution Spine20239—
+5K212701Eminent Spine 3D Cervical Interbody Fusion SystemEminent Spine20235—
+5K223494CD Horizon Spinal SystemMedtronic202317—
+5K222554EL CAPITAN Anterior Lumbar Interbody FusionAstura Medical20235—
+5K221542Galileo Vertebral Body Replacement DeviceBright Spine20230—
+5K223474PathLoc-TA Expandable Lumbar Cage SystemL&K BIOMED Co., Ltd.20231—
+5K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+5K223412LumiVy™ Lumbar IBF SystemVy Spine, LLC20235—
+5K223200Curiteva Navigation SystemCuriteva, Inc.20230—
+5K222806Kodiak C Spinal Implant SystemMet One Technologies, LLC20221—
+5K223105Tesera-K SC SystemKyocera Medical Technologies, Inc.20225—
+5K223251Hexanium PLIFSpinevision, S.A.S.20220—
+5K223510Matrix HA Fusion Porous Cervical IBF SystemInnovasis, Inc.20220—
+5K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc.20221—
+5K222516Mercury® II Spinal SystemSpinal Elements, Inc.20223—
+5K222903Tailored-H Cervical Stand Alone SystemBespoke Technologies, LLC20220—
+5K221578Hexanium ACIFSpinevision, S.A.S.20224—
+5K223065Adcura® Sagittae® Lateral Lumbar Interbody Fusion DevicesAdcura, Inc.20220—
+5K221545MectaLIF Anterior ExtensionMedacta International S.A.202226
+5K221751NuVasive Cohere ALIF System Intervertebral Body Fusion DeviceNu Vasive, Incorporated20223—
+5K222203DualXSLIM (R) T/PLIFAmplify Surgical, Inc.20223—
+5K221447Southern Anterior Screw Fixated Cage (SASCA)Southern Medical (Pty), Ltd.20220—
+5K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+5K221646CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™…Medtronic Sofamor Danek USA, Inc.202220—
+5K213417Ghost Spacer SystemLife Spine, Inc.20220—
+5K222561AlignAcuity Surgical Devices, LLC202214—
+5K220953ChoiceSpine TigerShark™ M, Modular Interbody SystemChoice Spine, LLC20220—
+5K220875HAcancellous PEEK-C Porous HA PEEK Cervical IBF SystemInnovasis, Inc.20224—
+5K220486Kentrospine PSS Pedicle Screw SystemRivarp Medical Private Limited20220—
+5K221535Align Lumbar Interbody Fusion SystemAcuity Surgical Devices, LLC20223—
+5K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+5K220610SOLO-LAurora Spine, Inc.20220—
+5K220711SeaSpine Meridian System, SeaSpine Meridian Anterior Plate SystemSeaSpine Orthopedics Corporation202210—
+5K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+5K220724CD Horizon™ Spinal System and PASS LP™ Spinal SystemMedicrea International20221—
+5K212126MediExpand Cervical Expandable VBR SystemCmf Medicon Surgical, Inc.20220—
+5K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+5K213118Dakota ALIF SystemPrecision Spine, Inc.20220—
+5K214047EL CAPITAN Anterior Lumbar Interbody Fusion SystemAstura Medical20223—
+5K213441PathLoc Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20222—
+5K213750VyLink™ Spinal Screw SystemVy Spine, LLC20221—
+5K214011Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™ TL Spinal…Medtronic Sofamor Danek USA, Inc.20221—
+5K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+5K213493Fortilink with TiPlus TechnologyParadigm Spine20220—
+5K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+5K212904SeaSpine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202115—
+5K212524Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.202155—
+5K212075ShurFit Lumbar Interbody SystemPrecision Spine, Inc.20211—
+5K212853Cervical Stand-Alone SystemEminent Spine, LLC202118—
+5K212831MectaLIF ExtensionMedacta International S.A.20211—
+5K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210—
+5K211805IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec…Alphatec Spine, Inc.202138—
+5K211689KEYSTONE PEEK Cage SystemShanghai Sanyou Medical Co, Ltd.20212—
+5K211769OneLIF Intervertebral Body Replacement SystemNovapproach Spine202112
+5K211704CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini PTC Spacer…Orthofix, Inc.20215—
+5K203607MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20210—
+5K212007VERTICALE Navigation InstrumentsSilony Medical GmbH20214—
+5K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+5K211958CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.202115—
+5K211111SureMAX-SA Cervical Standalone SystemAdditive Implants, Inc.20218—
+5K203003Pantheon IBFDPantheon Spinal20210—
+5K210583SeaSpine WaveForm™ A Interbody SystemSeaSpine Orthopedics Corporation202114—
+5K211258Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA…Medtronic Sofamor Danek USA, Inc.202175—
+5K210214NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody SystemNu Vasive, Incorporated20213—
+5K203311ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20213—
+5K210637CD Horizon™ Spinal SystemMedtronic202134—
+5K210061ProLift Lateral HELO FixatedLife Spine, Inc.20213—
+5K203520Blustone Synergy Interbody Fusion SystemBlustone Synergy, LLC20210—
+5K201457Auxein Brand Vertaux 5.5 mm Pedicle Screw SystemAuxein Medical Private Limited/7116420212—
+5K203361ProLift Wedge Expandable Spacer SystemLife Spine, Inc.20211—
+5K200551MectaLIF Transforaminal TiPEEKMedacta Inernational SA20214—
+5K203573RESPONSE Navigation InstrumentsOrthoPediatrics Corp.20210—
+5K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc.202135—
+5K203683CarboClear Lumbar Cage SystemCarbofix Orthpedics, Ltd.20211—
+5K203129NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) SystemPrecision Spine, Inc.20210—
+5K203201NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated202194—
+5K202495SIRION Lateral Lumbar Interbody FusionAstura Medical, LLC20216—
+5K200458Tailored-C Cervical Interbody Fusion SystemBespoke Technologies20203—
+5K202820Australis Anterior Lumbar Cage SystemPrism Surgical Designs Pty, Ltd.20200—
+5K201287Impulse Interbody Fusion SystemDegen Medical20208—
+5K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc.202067—
+5K200549Lucero Medical Cervical Cage SystemLucero Medical, LLC20200—
+5K202034aprevo Intervertebral Body Fusion DeviceCarlsmed, Inc.202017—
+5K201692NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated202067—
+5K202065DOLOMITE Anterior Cervical Stabilization SystemAstura Medical, LLC20203—
+5K202771CD Horizon Spinal SystemMedtronic202021—
+5K201917Piccolo Composite Proximal Tibia Plate SystemCarboFix Orthopedics, Ltd.20200—
+5K201453Fortilink Cages with TiPlus TechnologyParadigm Spine GmbH20204—
+5K200953NuVasive® Cohere® Thoracolumbar Interbody SystemNu Vasive, Incorporated2020141—
+5K202190Oculus-SA Lumbar Cage SystemNeurostructures20200—
+5K201820NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated2020156—
+5K200115Cavetto-SA Cervical Cage SystemNeurostructures, Inc.202019—
+5K201367FlareHawk TiHawk9 Interbody Fusion SystemIntegrity Implants, Inc.20202—
+5K201506Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical…Meditech Spine, LLC20200—
+5K201145X-Pac Expandable Lumbar Cage SystemExpanding Innovations, Inc.20204—
+5K201407CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.202054—
+5K200958MODULIF-A Anterior Lumbar Interbody Fusion SystemSpinal Stability, LLC20200—
+5K201926CarboClear® Pedicle Screw System, CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202010—