510(k) Report

Devices descending from K043316

1,005 later devices reach Rabea Spinal Implant through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K062151Box Peek VBR SystemInnovasis, Inc.2006175—
+1K060762Aesculap Peek Vertebral Body Replacement SystemAesculap, Inc.2006789—
+1K052533Kimba Spinal ImplantSignus Medizintechnik GmbH200541—
+1K052096Nubic Spinal ImplantSignus Medical, LLC2005790—
+1K051246Construx Mini Peek VBR SystemBlackstone Medical, Inc.2005834—
+2K151056Aesculap T-Space PEEK and XP Spinal SystemAesculap Implant Systems, LLC20150—
+2K140142Choice Spine Lumbar Spacer System (Sabre, Shark, Hornet, Harpoon)Choicespine, LP2014172—
+2K121581Box Peek VBR System,Innovasis, Inc.20121—
+2K120345Honour Spacer SystemNexxt Spine, LLC2012212—
+2K100305Eturn Spinal Implant Model Eturn XX-12; Eturn XX-16 Where XX=07, 09, 11, 13, or 15 and…Icotec20118—
+2K101812Construx Mini Peek Spacer SystemOrthofix, Inc.2010291—
+2K091425Quantum M Composite Nailing SystemN.M.B. Medical Applications, Ltd.201031—
+2K083311Aesculap Cespace Peek Intervertebral Body Fusion SystemAesculap Implant Systems, Inc.2009554—
+2K081849Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc.20087531
+2K071983Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace, Prospace, T-SpaceAesculap Implant Systems, Inc.20087881
+2K060350Construx PL/TL Peek Partial VBR SystemBlackstone Medical, Inc.2006754—
+3K241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc.20241—
+3K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+3K193412NEXXT MATRIXX SystemNexxt Spine, LLC20201—
+3K190684LxHA PEEK Lateral IBF SystemInnovasis, Inc.20190—
+3K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC201993—
+3K181899Roccia® PlifSilony Medical GmbH20180—
+3K181970MectaLIF Posterior ExtensionMedacta International S.A.20182—
+3K172480icotec Interbody Cage SystemIcotec AG20185—
+3K172185Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20177—
+3K171140Matrixx SystemNexxt Spine, LLC2017145—
+3K162446FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK…Orthofix, Inc.20166—
+3K162103Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine…Choicespine, LP2016161—
+3K161129Pillar SA PTCOrthofix, Inc.201619—
+3K153107Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine VEO™…Choicespine, LP2016171—
+3K151408LOSPA IS Spinal SystemCorentec Co., Ltd.20151—
+3K143450Ackermann Intervertebral Body Fusion DeviceAckermann Instrumente GmbH20150—
+3K151010Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.201521
+3K142152Construx Mini Peek; Spacer System, TI Spacer System, Cervical Stand Alone SystemOrthofix, Inc.2015280—
+3K133827A-Link ZOsteo Vasive, LLC2014262
+3K141376Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx, Struxxure Anterior…Nexxt Spine, LLC2014106—
+3K132852Peek Cage for the Vertebral SpineNeoortho Produtos Ortopedicos S/A20140—
+3K132999Cervical Stand Alone SystemOrthofix, Inc.2014281—
+3K132596Proposed OptimusCustom Spine, Inc.201451
+3K133529Camber Spine Coveris Cervical CageCamber Spine201410—
+3K132421Aesculap Peek XP Spinal Implant SystemAesculap Implant Systems, Inc.201414—
+3K132894Optio-C Anterior Cervical SystemZimmer Spine, Inc.201424—
+3K133126K7 Lumbar SpacersK7, LLC20131—
+3K131636Polarus ConnectAcumed, LLC20130—
+3K132774Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20133—
+3K130573Tyber Medical Interbody System; Acif, Alif, Plif, Tlif, DlifTyber Medical, LLC2013251—
+3K131077Life Spine Plateau Spacer SystemLife Spine201310—
+3K122588Vusion CS PlusOrtho Development Corp.2013206—
+3K123909Aesculap Cespace XPAesculap Implant System, Inc.20137—
+3K121649Construx Mini Peek TI Spacer SystemOrthofix2012289—
+3K122444Cervical CageEisertech, LLC201222—
+3K111820Synster Cervical Cage, Alif Cage, Plif Cage, Ptlif Cage, Tlif CageBm Korea Co., Ltd.201220—
+3K113478Plif CageEisertech, LLC2012269—
+3K112862Mecta-CMedacta International201114—
+3K110915Cervical CageEisertech, LLC201123—
+3K110864Biospine VBR SystemAesculap Implant Systems, LLC201149—
+3K111056Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.2011151
+3K102597Piccolo Composite Plate SystemN.M.B. Medical Applications, Ltd.201115—
+3K102369Piccolo Composite Nailing SystemN.M.B. Medical Applications, Ltd.2011161
+3K100889Endoskeleton TCTitan Spine, LLC2010455—
+3K100802Aesculap Implant Systems Sibd Spinal SystemAesculap Implant Systems, Inc.2010461—
+3K100497Quantum IM Composite Nailing System (Quantum Nailing System)N.M.B. Medical Applications, Ltd.201029—
+3K100043Coroent XLR Standalone SystemNuvasive, Inc.2010744—
+3K091301Life Spine Stand-Alone Spacer SystemLife Spine2009473—
+4K261810Vertiwedge® Intraosseous SystemFoundation Surgical Group20260—
+4K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+4K253559Ventana™ A Anterior Lumbar Interbody SystemSpinal Elements, Inc.20260—
+4K251016MectaLIF 3D MetalMedacta International S.A.20250—
+4K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+4K240838Spectrum Spine Cervical Cage SystemSpectrum Spine, Inc.20244—
+4K232792icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec…Icotec AG20240—
+4K232481RIGEL™ 3DR Anterior Cervical Corpectomy SystemMiRus, LLC20230—
+4K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+4K222015Integral Titanium Cervical InterbodyNvision Biomedical Technologies, Inc.20231—
+4K221162UniVy OsteoVy Cervical IBF SystemVy Spine, LLC20222—
+4K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+4K202266Reliance Cervical IBF SystemReliance Medical Systems, LLC20223—
+4K212831MectaLIF ExtensionMedacta International S.A.20211—
+4K210590Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20210—
+4K210470C-CURVE Interbody Fusion DeviceMedicrea International SA20210—
+4K211704CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini PTC Spacer…Orthofix, Inc.20215—
+4K201671A-Link ZAcuity Surgical Devices, LLC202125—
+4K210359Hexanium TLIFSpinevision, S.A.S.20211—
+4K203683CarboClear Lumbar Cage SystemCarbofix Orthpedics, Ltd.20211—
+4K193000Hexanium® ACIFSpinevision, S.A.S.202014—
+4K201917Piccolo Composite Proximal Tibia Plate SystemCarboFix Orthopedics, Ltd.20200—
+4K200953NuVasive® Cohere® Thoracolumbar Interbody SystemNu Vasive, Incorporated2020141—
+4K202190Oculus-SA Lumbar Cage SystemNeurostructures20200—
+4K201367FlareHawk TiHawk9 Interbody Fusion SystemIntegrity Implants, Inc.20202—
+4K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC202025—
+4K200969NEXXT MATRIXX SystemNexxt Spine, LLC20200—
+4K200352Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20202—
+4K193457AUDERE Lumbar Spacer SystemMet One Technologies20201—
+4K192145Galileo Vertebral Body Replacement DeviceBright Spine20201—
+4K200543NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) SystemNexxt Spine, LLC202072—
+4K192897icotec Cervical CageIcotec AG20201—
+4K193378CarboClear Lumbar Cage SystemCarboFix Orthopedics, Ltd.20202—
+4K193370Nexxt Matrixx SystemNexxt Spine, LLC20202—
+4K192687TrellOss™-L MPFNexxt Spine, LLC20201—
+4K191834Stand-Alone ALIF Titanium SystemLife Spine, Inc.20190—