510(k) Report

Devices descending from K841189

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K201362CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System, Kyphon™ HV-R™ Bone CementMedtronic202038—
+6K201006K2M Navigation InstrumentsK2m, Inc.20200—
+6K201500Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar SpacerLife Spine, Inc.20203—
+6K201087CORBEL SpacersGlobus Medical, Inc.202036—
+6K201648Sterispine™ PSSafe Orthopaedics202011
+6K201614TxTiHA IBF System, AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.2020471
+6K200685RIGEL 3DR Anterior Cervical Interbody Fusion SystemMiRus, LLC20200—
+6K200541Hive™ Stand-alone Anterior Lumbar Interbody SystemHd Lifesciences, LLC20201—
+6K200245EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine SystemMedos International Sàrl202012—
+6K193636SeaSpine Reef TH SystemSeaSpine Orthopedics Corporation202056—
+6K200070ARx Spinal SystemLife Spine, Inc.20209—
+6K200613Tritanium® X TL Expandable Curved Posterior Lumbar CageStryker Corporation20205—
+6K200052CONSTRUX Mini PTC Spacer System, FORZA PTC Spacer System, PILLAR SA PTC Spacer SystemOrthofix, Inc.202013—
+6K200312Tryptik TiSpineart20202—
+6K200552EVOS Lumbar Interbody SystemCutting Edge Spine, LLC20200—
+6K192897icotec Cervical CageIcotec AG20201—
+6K200267LOSPA® IS™ Spinal Fixation SystemCorentec Co., Ltd.20201—
+6K193472OrthoCircle Spine Pedicle Screw SystemOrthocircle Spine20200—
+6K193320KMTI Tesera SA Anterior Lumbar Interbody Fusion (ALIF) SystemKyocera Medical Technologies, Inc.20203—
+6K193258ProLift Expandable SystemLife Spine, Inc.20203—
+6K193365M.U.S.T. Pedicle Screw SystemMedacta International S.A.20207—
+6K190981NEX-D2 Posterior Fixation SystemNext Orthosurgical20200—
+6K192115SABLE Expandable SpacerGlobus Medical, Inc.202037—
+6K193645nva, nvp, and nvtNvision Biomedical Technologies, Inc.20203—
+6K192497EVOL ha - D Lateral Interbody Fusion SystemCutting Edge Spine, LLC20201—
+6K193359SureMAX Family of Cervical SpacersAdditive Implants, Inc.202014—
+6K192718Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D TechnologyPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20195—
+6K1920444CIS Marlin PEEK ACIF CageSolco Biomedical Co., Ltd.20190—
+6K182731Corelink Navigation InstrumentsCorelink, LLC20195—
+6K191118Avanti Distal Radius and Forearm SystemAvanti Orthopaedics, Inc.20191—
+6K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+6K192248Cortina™ [MAX] Lumbar Cage SystemNeurostructures, Inc.20190—
+6K192336Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.201917—
+6K191477AEON-C Stand Alone SystemHuvexel Co., Ltd.201910—
+6K191134IB3D AlifMedicrea International SA20191—
+6K190426ALTA Anterior Cervical Corpectomy SystemAstura Medical, LLC20193—
+6K192760NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2019163—
+6K192434DualX Lumbar Intervertebral Body Fusion DeviceAmplify Surgical, Inc.20190—
+6K192208CORNICE Cervical Spacer SystemLegend Spine Technologies20190—
+6K191854Premia Spine XL InstrumentsPremia Spine, Ltd.20190—
+6K191391HEDRON Lumbar SpacersGlobus Medical, Inc.201984—
+6K191243HEDRON Cervical SpacersGlobus Medical, Inc.201936—
+6K191148Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™ Fenestrated Screw SetMedtronic Sofamor Danek USA, Inc.201950—
+6K191339Zavation eZspand Interbody SystemZavation Medical Products, LLC20195—
+6K190870Cervical Spinal Truss System-Stand Alone (CSTS-SA)4Web, Inc.201910—
+6K191311ATEC Lateral Interbody SystemAlphatec Spine, Inc.201978—
+6K191575ARx Spinal SystemLife Spine, Inc.201910—
+6K190885Elevation Spine Saber-C SystemElevation Spine201925—
+6K191835CREO Stabilization System, Navigation Instruments, ExcelsiusGPS InstrumentsGlobus Medical, Inc.20192—
+6K183091Elaris Pedicle Screw SystemSpinewelding AG20190—
+6K190291Addivation Medical Cervical Interbody SystemAddivation Medical, LLC20190—
+6K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+6K190680Favo S-TlifSilony Medical GmbH20190—
+6K182158UNiD Patient-matched PLIF cageMedicrea International SA201921—
+6K183243Velofix TLIF CageU&I Corporation20190—
+6K190498Fortilink® IBF System with TETRAfuse®3D Technology, include the following designs…Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20197—
+6K183064TxTi IBF SystemInnovasis, Inc.2019481
+6K190877Juliet® Ti LL Lumbar Interbody DeviceSpineart201911
+6K183560Luna 3D GEN2 Interbody Fusion SystemBenvenue Medical, Inc.20192—
+6K190092UNiD Patient specific 3D printed TLIF cageMedicrea International SA201913—
+6K190376PASS LP Spinal SystemMedicrea International SA201915
+6K190380nvcNvision Biomedical Technologies, Inc.20193—
+6K183426MectaLIF Anterior Stand Alone ExtensionMedacta International S.A.20191—
+6K183430Modular Spinal Fixation SystemLife Spine, Inc.20192—
+6K190322SCARLET® AC-T Secured Anterior Cervical CageSpineart20191—
+6K183259Idys™ TLIF TiVacClariance, Sas20191—
+6K183049Reliance Lumbar IBF SystemReliance Medical Systems, LLC20197—
+6K182885Atlantis™ Anterior Cervical Plate, Divergence™ Anterior Cervical Fusion System, Premier™…Medtronic Sofamor Danek USA, Inc.20198—
+6K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+6K183447EIT Cellular Titanium Lumbar Cage - T/PLIFEit Emerging Implant Technologies GmbH2019131—
+6K180230NEST Interbody SystemPaonan Biotech Co., Ltd.20191—
+6K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20198—
+6K182210TiWAVE-L Porous Titanium Lumbar CageKalitec Medical, LLC20193—
+6K182114FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20196—
+6K180909REVEL SpacersGlobus Medical, Inc.201837—
+6K182584Lucent® XPSpinal Elements, Inc.20183—
+6K180498NuVasive Reline Fenestrated Screws, High V+ Bone CementNu Vasive, Incorporated201841—
+6K182746ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc.2018110—
+6K181140Axis Chena Cervical PEEK Spacer SystemAxis Orthopaedics20182—
+6K181590Neurostructures Cavetto® [MAX] Cervical Cage SystemNeurostructures, Inc.20180—
+6K181837Spinal Elements Ti-Bond coated devicesSpinal Elements, Inc.201898—
+6K182322Duo Lumbar Interbody Fusion DeviceSpineology, Inc.20182—
+6K181980OsseoScrew SystemAlphatec Spine, Inc.20181—
+6K181337Sypher Spacer SystemBiogennix, LLC20180—
+6K181821MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20181—
+6K181655Renovis S180 Lateral Lumbar Interbody Fusion SystemRenovis Surgical Technologies20184—
+6K181380LnK Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.201810—
+6K181483Tranquil Interbody SystemNexus Spine, LLC20186—
+6K180373CancelleX Porous Titanium Lumbar Interbody DeviceXenco Medical, LLC20180—
+6K181677Kodiak Spinal Fixation SystemAlphatec Spine, Inc.201870—
+6K180076Ti 3Z Interbody SystemZavation Medical Products, LLC20184—
+6K181339Altus Spine Pedicle Screw SystemAltus Partners, LLC20186—
+6K173487CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.201841—
+6K181246Zavation IBF SystemZavation Medical Products, LLC201822—
+6K181139OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20188—
+6K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+6K181203Juliet TiSpineart20181—
+6K180364HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC2018106—
+6K172788MONET™ Anterior Cervical Interbody Fusion Cage SystemCtl Medical Corporation20181—
+6K180674EVOL® ha-C Cervical Interbody Fusion SystemCutting Edge Spine, LLC20183—