510(k) Report

Devices descending from K841189

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K132582Exactech Acapella One Cervical Spacer SystemExactech, Inc.2014471
+6K132991C-Box Peek Cervical IbfInnovasis, Inc.20149—
+6K133369Tiger Spine SystemCorelink, LLC201429—
+6K132878M.U.S.T. ExtensionMedacta International201328—
+6K133188Mantis & Mantis Redux Spinal System, Radius Spinal System, Trio & Trio+ Spinal Fixation…Stryker Spine201384—
+6K132757Everest Spinal SystemK2m, Inc.201341—
+6K132303Implanet Spine SystemImplanet, S.A.201315—
+6K132361Everest Spinal SystemK2m, Inc.201334—
+6K131888T2 XVBR Spinal System, T2 Altitude Expandable Corpectomy DeviceMedtronic Sofamor Danek, Inc.20130—
+6K131429Reliance Cervical Ibf SystemReliance Medical Systems, LLC201324—
+6K131723Coroent Single Tab SystemNuvasive, Inc.2013466—
+6K131250Tiger Spine SystemCorelink, LLC201340—
+6K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)201370—
+6K131784Range Spinal SystemK2m, Inc.201334—
+6K130948C-Fuse Cervical Intervertebral Body Fusion SystemSouthern Spine, LLC201313—
+6K131951Irix-C Cervical Integrated Fusion SystemX-Spine Systems, Inc.201312—
+6K131538Caplox II Pedicle Screw System/Towerlox Pedicle Screw SystemCaptiva Spine20136—
+6K130932Firebird Spinal Fixation SystemOrthofix, Inc.2013811
+6K131343Reform Pedicle Screw SystemSpinal USA201331—
+6K130279Reform Pedicle Screw SystemSpinal USA201331—
+6K124012Infill Oblique Tlif DevicePinnacle Spine Group, LLC20136—
+6K122801Providence Cervical CageProvidence Medical Technology, Inc.20131—
+6K130506Imse P-TlifInstitute of Musculoskeletal Science & Education20130—
+6K131030Range Spinal SystemK2m, Inc.201334—
+6K130330Range Spinal SystemK2m, Inc.201336—
+6K130434Octane Straight, Octane Straight - Lordotic, Octane Straight I/R, Octane Straight I/R -…Exactech, Inc.201311—
+6K123461Staxx (R) IB SystemSpine Wave, Inc.2013251
+6K130306Incite Anchored Cervical Interbody DeviceIncite Innovation, LLC20131—
+6K123767Lanx Fusion System- SALanx, Inc.20133244
+6K123487Gso GS1 Cannulated Screw SystemGold Standard Orthopaedics, LLC20130—
+6K123993Solus Anterior Lumbar Interbody Fusion (Alif) SystemAlphatec Spine, Inc.20130—
+6K123656Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc.201339—
+6K123412Range Spinal System, Small Strature ComponentsK2m, Inc.201334—
+6K120603Varilift -CWenzel Spine2013193—
+6K123281Acculif TL-Peek CageCoalign Innovations, Inc.2013146—
+6K123231Caliber SpacersGlobus Medical, Inc.2013657—
+6K123752Acculif TL and PL CageCoalign Innovations, Inc.2013676—
+6K121254Camber Spine Technologies TLS 5.0 Inerbody CageCamber Spine Technologies201340—
+6K123180Falcon SpacerSynthes (USA) Products, LLC2013147—
+6K121693A-Wedge Anterior Interbody System (a-Wedge Ais)Sapphire Medical Group, Inc.201221—
+6K123207Primalif TM Llif Unitary Peek Lateral Lumbar Interbody Fusion SystemOsteomed LP201216—
+6K123246CD Horizon Spire Z Spinal SystemMedtronic Sofamor Danek20122—
+6K122956Fuselox Lumbar Interbody Fusion DeviceCaptiva Spine20122—
+6K122226Revere Stabilization SystemGlobus Medical, Inc.2012225—
+6K122021Sterispine LC CageSafe Orthopaedics20122—
+6K113285LDR Spine Usa Avenue L Interbody FusionLdr Spine USA, Inc.2012199—
+6K121922Beacon Stabilization SystemGlobus Medical, Inc.20129—
+6K121733Infill Intervertebral Body Fusion DevicePinnacle Spine Group, LLC201221—
+6K120396Reliance Cervical Ibf SystemReliance Medical Systems, LLC201225—
+6K120101Independence SpacerGlobus Medical, Inc.2012224—
+6K113447Rise SpacerGlobus Medical, Inc.2012691—
+6K113527Opticage Interbody Fusion DeviceInterventional Spine, Inc.2012103—
+6K112459Synthes Zero-PSynthes Spine Co.Lp2011277—
+6K113465Acculif TL CageCoalign Innovations, Inc.2011718—
+6K112095Acculif TL-Peek Ibf CageCoalign Innovations, Inc.2011319—
+6K112068Synthes Zero-P Variable Angle (VA)Synthes Spine Co.Lp2011331
+6K111675VU C*Pod Intervertebral Body Fusion DeviceTheken Spine, LLC201162—
+6K110522Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc.2011106—
+6K103111Forza Spacer SystemOrthofix, Inc.20113431
+6K102322Stingray Cervical Cage; Shark Implant (Plif); Bull Shark Implant (Plif); Tiger Implant…Omni Surgical, L.P.20116—
+6K102323Cervical Standalone Intervertebral Body Fusion DeviceTheken Spine, LLC201062—
+6K100037Advanced Vertebral Solutions Express BFDAdvanced Vertebral Solutions, LLC20100—
+6K101288Staxx XD SystemSpine Wave, Inc.201051
+6K100210TRANS1 Lateral Intervertebral Fusion Device, TTrans1 Incorporated2010175—
+6K100820Wenzel Spine Varilift Interbody Fusion SystemWenzel Spine201016—
+6K094042Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek2010397—
+6K093434Vertex Reconstruction System and Vertex Select Reconstruction SystemMedtronic Sofamor Danek20097—
+6K080401Shell Cage, Wave Cage, Loop CageAdvanced Medical Technologies AG2008840—
+6K073291Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.20081,103—
+6K080083Intrepid Spinal SystemMedtronic Sofamor Danek20089328
+6K073502Vertebron VBR SystemVertebron, Inc.200812—
+6K073420Blackstone Ascent Multiaxial ScrewsBlackstone Medical, Inc.20089—
+6K052096Nubic Spinal ImplantSignus Medical, LLC2005790—
+7K262726NeckTune™ SA Cervical CageMedyssey Co., Ltd.20260—
+7K262025Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis…INNO Holdings Inc. DBA Innovasis20260—
+7K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc.20260—
+7K262489BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20260—
+7K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+7K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+7K253943Tiger 2 SystemZavation Medical Products, LLC20260—
+7K262094E3D™-C Interbody SystemEvolution Spine20260—
+7K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+7K253921VERTICALE® Navigation InstrumentsSilony Medical GmbH20260—
+7K261279DeltaNEC Interbody SystemNexus Spine20260—
+7K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+7K253151Fule Interbody Fusion Cage SystemBeijing Fule Science & Technology Development Co., Ltd.20260—
+7K260286Dynamo™ Spinal Cement; Salvo® Spine SystemSpine Wave, Inc.20260—
+7K253195TAURUS Posterior Occipital-Cervico-Thoracic Spinal SystemsZheJiang Decans Medical Devices Co., Ltd.20260—
+7K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+7K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, Inc.20260—
+7K261374LigaPASS™ SystemMedicrea International S.A.S20260—
+7K261145Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC20260—
+7K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+7K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+7K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20260—
+7K260660SABER-C SystemElevation Spine20261—
+7K260549ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemZsfab, Inc.20260—
+7K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+7K252774Uni-C Cervical Cage SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+7K260340HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC…HC Biologics, LLC20260—