510(k) Report

Devices descending from K003043

1,819 later devices reach Surgical Titanium Mesh System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K151352CONCORDE Bullet Spinal SystemMedos International SARL20153—
+3K151056Aesculap T-Space PEEK and XP Spinal SystemAesculap Implant Systems, LLC20150—
+3K150847Foundation Interbody DevicesCorelink, LLC201529—
+3K151010Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.201521
+3K142005SpineFab Vertebral Body Replacement (VBR) SystemOxford Performance Materials201513—
+3K133827A-Link ZOsteo Vasive, LLC2014262
+3K140577Innesis Peek TL CageBk Meditech, Co., Ltd.20142—
+3K133717Longbow Spacer SystemLife Spine20149—
+3K133813Flxfit Intervertebral Body Fusion DeviceExpanding Orthopedics, Inc.2014137—
+3K141376Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx, Struxxure Anterior…Nexxt Spine, LLC2014106—
+3K140066Infill CervicalPinnacle Spine Group, LLC20140—
+3K123607Octane Elevate Spinal Implant SystemExactech, Inc.20141—
+3K133802Ais Modulift VBR SystemAesculap Implant System, Inc.201448—
+3K132738Cogent Med-LifCogent Spine, LLC201413—
+3K132596Proposed OptimusCustom Spine, Inc.201451
+3K132483Innesis Peek Cervical CageBk Meditech, Co., Ltd.20140—
+3K133529Camber Spine Coveris Cervical CageCamber Spine201410—
+3K132894Optio-C Anterior Cervical SystemZimmer Spine, Inc.201424—
+3K123758Tasmin RSignus Medizintechnik GmbH20141—
+3K133321Alamo CAlliance Partners, LLC20143—
+3K131350Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc.2013214
+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—
+3K131671MectalifMedacta International201322—
+3K122639Synthes Syncage Evolution SpacerSynthes (USA) Products, LLC2013143—
+3K122989Biomet Lateral Spacer SystemBiomet Spine (Aka Ebi, LLC)2012171—
+3K122444Cervical CageEisertech, LLC201222—
+3K120966Depuy Pulse Lumbar Cage SystemMedos International SARL201225—
+3K121107Fortify Integrated Corpectomy Spacers, (Fortify I and Fortify I-R)Globus Medical, Inc.2012214—
+3K120517Depuy Pulse Cervical Cage SystemMedos International SARL20123—
+3K112696Twin Peaks Lumbar CageQualgenix, LLC20120—
+3K120024Mectalif TransforaminalMedacta International S.A.201223—
+3K111726Pathway AvidCustom Spine, Inc.201295—
+3K112862Mecta-CMedacta International201114—
+3K113348Cougar SystemJohnson & Johnson2011591—
+3K111119Trabecular Metal (TM) Fusion DeviceZimmer Spine, Inc.201152—
+3K112444Anatomic Peek Cervical Fusion SystemMedtronic Sofamor Danck USA, Inc.2011324—
+3K112359Prow FusionNlt Spine, Ltd.2011601—
+3K110783Venus Interbody Fixation System- Venus Plif/Tlif, Alif Peek CageL&K BIOMED Co., Ltd.201138—
+3K111264Cornerstone (R) PSR Cervical Fusion SystemMedtronic Sofamor Danek USA2011331—
+3K110694Concorde Bullet Spinal SystemJohnson & Johnson2011227—
+3K111774Pathway Model 07XXXXCustom Spine201115—
+3K111835Plateau Spacer SystemLife Spine, Inc.2011120—
+3K110843Aleutian Spacer SystemK2m, Inc.2011589—
+3K110927MectalifMedacta International2011301
+3K110454Cougar LS Lateral Cage SystemJohnson & Johnson2011602—
+3K111056Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.2011151
+3K102606Avs Anchor-C Cervical Cage SystemStryker Spine20113841
+3K103169AleuttianK2m, Inc.2011572—
+3K103488Concorde Bullet Cage SystemJohnson and Johnson201129—
+3K102597Piccolo Composite Plate SystemN.M.B. Medical Applications, Ltd.201115—
+3K102369Piccolo Composite Nailing SystemN.M.B. Medical Applications, Ltd.2011161
+3K101923Concorde Curve SystemDepuy Spine2010609—
+3K093093Small Plateau Spacer SystemLife Spine2010393—
+3K101812Construx Mini Peek Spacer SystemOrthofix, Inc.2010291—
+3K101302Aleutian Ibf SystemK2m, Inc.2010595—
+3K100497Quantum IM Composite Nailing System (Quantum Nailing System)N.M.B. Medical Applications, Ltd.201029—
+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—
+3K080822VU Apod Intervertabral Body Fusion DeviceTheken Spine, LLC20087081
+3K072326Ostapek VBR SystemCo-Ligne AG20081—
+3K071983Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace, Prospace, T-SpaceAesculap Implant Systems, Inc.20087881
+3K071031VU E*Pod Vertebral Body ReplacementTheken Spine, LLC2007119—
+3K070786X-Pod Adjustable Vertebral Body ReplacementTheken Spine, LLC20070—
+3K070218Vertiflex Octane Peek Vertebral Body Replacement (Peek VBR)Vertiflex (Tm), Incorporated200760—
+3K062151Box Peek VBR SystemInnovasis, Inc.2006175—
+3K061752Spinal Usa VBR SystemSpinal USA20060—
+3K052670Staxx XD SystemSpine Wave, Inc.20068—
+3K052533Kimba Spinal ImplantSignus Medizintechnik GmbH200541—
+3K052746Concorde VBR Spinal SystemDepuy Spine, Inc.20051,149—
+3K050449Quantum Vertebral Body ReplacementQuantum Orthopedics, Inc.2005197—
+3K043479MC+ Partial VBRLdr Spine USA20051,214—
+3K043349Open Radiotransparent Intersomatic Implant (Roi)Ldr Spine USA2005134—
+3K041888Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH20041,586—
+3K033109Ellys and Aurys Vertebral Body ReplacementsScient'X20041,218—
+4K261810Vertiwedge® Intraosseous SystemFoundation Surgical Group20260—
+4K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+4K253213SAGI Cervical Cage SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+4K242303MOD-COrthomod, LLC20260—
+4K253559Ventana™ A Anterior Lumbar Interbody SystemSpinal Elements, Inc.20260—
+4K252219Cervical Interbody and VBR Fusion SystemSync Surgical20260—
+4K253158VyBrate™ VBR SystemVy Spine, LLC20260—
+4K251016MectaLIF 3D MetalMedacta International S.A.20250—
+4K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc.20251—
+4K241073DZ-Tabone Intervertebral Body Fusion DeviceShenzhen Dazhou Medical Technology Co., Ltd.20240—
+4K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+4K242267Gemini Medical Cage SystemZheJiang Decans Medical Devices Co., Ltd.20241—
+4K233375Tranquil-L Interbody SystemNexus Spine, LLC20240—
+4K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+4K230478Acro Composites Interbody SystemAcro Composites, LLC20230—
+4K231704Pro-Link® & Pro-Link® Ti Barbs Cervical Spacer SystemLife Spine, Inc.20230—
+4K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+4K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+4K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+4K222015Integral Titanium Cervical InterbodyNvision Biomedical Technologies, Inc.20231—
+4K230329F3D Interbody SystemCorelink, LLC20230—
+4K223430ProLift Micro Expandable Spacer SystemLife Spine, Inc.20236—