510(k) Report

Devices descending from K841189

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K140759Bengal System, Bengal Stackable System, Concorde Bullet Lumbar, Concorde Inline Lumbar…Medos International SARL2014204—
+3K132738Cogent Med-LifCogent Spine, LLC201413—
+3K132596Proposed OptimusCustom Spine, Inc.201451
+3K133529Camber Spine Coveris Cervical CageCamber Spine201410—
+3K132894Optio-C Anterior Cervical SystemZimmer Spine, Inc.201424—
+3K131724Pioneer Maxfuse Vertebral Body Replacement DevicePioneer Surgical Technology, Inc.201373—
+3K131082Interform Interbody Cage SystemNext Orthosurgical2013595—
+3K131077Life Spine Plateau Spacer SystemLife Spine201310—
+3K120464Innesis Peek CageBk Meditech, Co., Ltd.20136—
+3K122989Biomet Lateral Spacer SystemBiomet Spine (Aka Ebi, LLC)2012171—
+3K122622EndurameshLucero Medical, LLC20120—
+3K122444Cervical CageEisertech, LLC201222—
+3K122317Tetris IISignus Medizintechnik GmbH20122—
+3K112561Nuvasive Coroent NO-Profile SystemNuvasive, Inc.201212—
+3K111726Pathway AvidCustom Spine, Inc.201295—
+3K113348Cougar SystemJohnson & Johnson2011591—
+3K110562Telamon Peek Spinal SystemMedtronic Sofamor Danek USA2011306—
+3K112359Prow FusionNlt Spine, Ltd.2011601—
+3K103320Synthes XRLSynthes Spine Co.Lp201131
+3K112014Zyston Straight Spacer SystemBiomet Spine2011174—
+3K112756Fortify (TM) and Fortify (TM)-R Corpectomy SpacersGlobus Medical, Inc.2011268—
+3K111774Pathway Model 07XXXXCustom Spine201115—
+3K094025Crescent Spinal SystemMedtronic Sofamor Danek2010838—
+3K083186Aesculap Hydrolift VBR SystemAesculap Implant System, Inc.201051—
+3K091425Quantum M Composite Nailing SystemN.M.B. Medical Applications, Ltd.201031—
+3K090353Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek2009796—
+3K091974Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20096561
+3K091381Ibex Spinal SystemEbi, L.P.2009181—
+3K081917Depuy Spine Bengal, Concorde, Cougar, Devex and Leopard SystemsDepuy Spine, Inc.20091,008—
+3K090899Depuy Spine Lateral SystemDepuy Spine, Inc.2009932—
+3K083311Aesculap Cespace Peek Intervertebral Body Fusion SystemAesculap Implant Systems, Inc.2009554—
+3K082712Theken Spine VU Epod and VU Lpod SystemTheken Spine, LLC2009118—
+3K082236CD Horizon Spinal SystemMedtronic Sofamor Danek2008779—
+3K081849Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc.20087531
+3K080822VU Apod Intervertabral Body Fusion DeviceTheken Spine, LLC20087081
+3K072326Ostapek VBR SystemCo-Ligne AG20081—
+3K080615Endoskeleton TA Interbody Fusion Device (Ibd)Titan Spine, LLC2008564—
+3K073109Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd.2008907—
+3K073562Modification to Viper Spine SystemDepuy Spine, Inc.2008213—
+3K080568X-Mesh Expandable Cage SystemDepuy Spine, Inc.2008615—
+3K071983Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace, Prospace, T-SpaceAesculap Implant Systems, Inc.20087881
+3K071274Gso GS1 SpacerGold Standard Orthopedics, LLC20070—
+3K071031VU E*Pod Vertebral Body ReplacementTheken Spine, LLC2007119—
+3K070786X-Pod Adjustable Vertebral Body ReplacementTheken Spine, LLC20070—
+3K063670Modifications to CD Horizon Spinal SystemMedtronic Sofamor Danek2007821—
+3K070082XY Cor Spinal Implant for Minimal Invasive Spinal SurgeryVertebration,Inc2007641—
+3K062151Box Peek VBR SystemInnovasis, Inc.2006175—
+3K061891Synex IISynthes Spine Co.Lp200677—
+3K062132Avs PL Peek Spacer SystemStryker Spine2006243—
+3K061938Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc.2006152—
+3K061915CD Horizon Spinal SystemMedtronic Sofamor Danek200654—
+3K060719Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2006992—
+3K053508Synfix-LRSynthes Spine Co.Lp2006391
+3K052170Seaspine VBR SystemSeaspine, Inc.200513—
+3K053080Graftcage AcxOsteotech, Inc.20050—
+3K052931Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2005993—
+3K052747Modification to:CD Horizon Spinal SystemMedtronic Sofamor Danek2005528—
+3K052746Concorde VBR Spinal SystemDepuy Spine, Inc.20051,149—
+3K052609Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek200554—
+3K050997Expanse Vertebral Body Replacement DeviceFlexuspine, Inc.20050—
+3K052384Lanx VBR SystemLanx, LLC2005455—
+3K052187Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005780—
+3K051674CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2005587—
+3K050449Quantum Vertebral Body ReplacementQuantum Orthopedics, Inc.2005197—
+3K043479MC+ Partial VBRLdr Spine USA20051,214—
+3K051069Nonresorbable Centraloc Tibial Screw & WasherArthrotek, Inc.20050—
+3K043349Open Radiotransparent Intersomatic Implant (Roi)Ldr Spine USA2005134—
+3K050348CO Vertebral Body ReplacementScient'X20052—
+3K043206Pioneer Vertebral Body Replacement Device (Pioneer Vertebral Spacer)Pioneer Surgical Technology20051,571—
+3K043566Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2005726—
+3K042713Fidji-Vertebral Body Replacement Type 5Spine Next America Corporation20040—
+3K042714Fidji-Vertebral Body Replacement Type 1, 2, 3 and 4Spine Next America Corporation2004838—
+3K042930Spacevision Cage SystemSpine Vision, Inc.20041,440—
+3K041197Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2004994—
+3K033926Hourglass Vertebral Body SpacerMedtronic Sofamor Danek2004763—
+3K041556Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek20041,002—
+3K033663Spinal Concepts Inc. CodaSpinal Concepts, Inc.20041—
+3K040536Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek20041,150—
+3K040422Modification to Verte-StackMedtronic Sofamor Danek20041,002—
+3K031757Peek Tetris Spinal ImplantSignus Medical, LLC20031,702—
+4K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+4K261031Poseidon STSignus Medinzintechnik GmbH20260—
+4K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+4K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—
+4K253559Ventana™ A Anterior Lumbar Interbody SystemSpinal Elements, Inc.20260—
+4K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+4K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc.20251—
+4K241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc.20241—
+4K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+4K241992Catalyft™ LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.20240—
+4K241438Signus Tetris™ St; Signus Tetris™ R StSignus Medizintechnik GmbH20240—
+4K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+4K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+4K233375Tranquil-L Interbody SystemNexus Spine, LLC20240—
+4K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+4K232481RIGEL™ 3DR Anterior Cervical Corpectomy SystemMiRus, LLC20230—
+4K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+4K222874CarboClear Cervical Cage System, CarboClear Cervical VBR SystemCarbofix Orthpedics, Ltd.20230—
+4K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+4K222015Integral Titanium Cervical InterbodyNvision Biomedical Technologies, Inc.20231—