510(k) Report

Devices descending from K003709

1,714 later devices reach Surgical Dynamics Mesh Cage System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K151064Solitaire-C Cervical Spacer System, C-Thru Anterior Spinal System, Breckenridge Small…Biomet Spine201517—
+4K151483Biomet Spine Fusion SystemBiomet Spine, LLC20154—
+4K151010Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.201521
+4K142005SpineFab Vertebral Body Replacement (VBR) SystemOxford Performance Materials201513—
+4K143258PLIF STS, TLIF STS, OLIF STS (Spinal Truss System)4Web, Inc.2015211—
+4K141665NuVasive CoRoent SystemNuvasive, Inc.2015588—
+4K141798Sypher Spacer SystemBiogennix, LLC20151—
+4K143126Renovis S141 Lumbar Interbody Cage SystemRenovis Surgical Technologies2015237—
+4K142940Endoskeleton TCS SystemTitan Spine, LLC20151112
+4K142030STGC-LordoticCardinal Spine, LLC201558—
+4K142152Construx Mini Peek; Spacer System, TI Spacer System, Cervical Stand Alone SystemOrthofix, Inc.2015280—
+4K141135Juliet LLSpineart2014146—
+4K142016CAPRIK2m, Inc.201412—
+4K140319Coroent TI-C SystemNuvasive, Inc.2014590—
+4K133717Longbow Spacer SystemLife Spine20149—
+4K140563Lateral VBR SystemNu Vasive, Incorporated20140—
+4K133813Flxfit Intervertebral Body Fusion DeviceExpanding Orthopedics, Inc.2014137—
+4K132852Peek Cage for the Vertebral SpineNeoortho Produtos Ortopedicos S/A20140—
+4K140066Infill CervicalPinnacle Spine Group, LLC20140—
+4K133802Ais Modulift VBR SystemAesculap Implant System, Inc.201448—
+4K132738Cogent Med-LifCogent Spine, LLC201413—
+4K132999Cervical Stand Alone SystemOrthofix, Inc.2014281—
+4K132596Proposed OptimusCustom Spine, Inc.201451
+4K133721Infill 41-Tlif Convex Oblique Device, Infill 43-Tlif Contour Oblique, Infill 44-Tlif…Pinnacle Spine Group, LLC20145—
+4K140106S128 Anterior Lumbar Interbody Fusion (Alif) SystemRenovis Surgical Technologies, Inc.2014265—
+4K132991C-Box Peek Cervical IbfInnovasis, Inc.20149—
+4K133557Juliet LL Lateral Lumbar CageSpineart2014147—
+4K132421Aesculap Peek XP Spinal Implant SystemAesculap Implant Systems, Inc.201414—
+4K133321Alamo CAlliance Partners, LLC20143—
+4K131636Polarus ConnectAcumed, LLC20130—
+4K131981Cezanne II Interbody Fusion SystemAccel Spine201354
+4K132774Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20133—
+4K130573Tyber Medical Interbody System; Acif, Alif, Plif, Tlif, DlifTyber Medical, LLC2013251—
+4K130948C-Fuse Cervical Intervertebral Body Fusion SystemSouthern Spine, LLC201313—
+4K131671MectalifMedacta International201322—
+4K122588Vusion CS PlusOrtho Development Corp.2013206—
+4K122639Synthes Syncage Evolution SpacerSynthes (USA) Products, LLC2013143—
+4K130506Imse P-TlifInstitute of Musculoskeletal Science & Education20130—
+4K123909Aesculap Cespace XPAesculap Implant System, Inc.20137—
+4K123767Lanx Fusion System- SALanx, Inc.20133244
+4K121254Camber Spine Technologies TLS 5.0 Inerbody CageCamber Spine Technologies201340—
+4K121649Construx Mini Peek TI Spacer SystemOrthofix2012289—
+4K123207Primalif TM Llif Unitary Peek Lateral Lumbar Interbody Fusion SystemOsteomed LP201216—
+4K122956Fuselox Lumbar Interbody Fusion DeviceCaptiva Spine20122—
+4K122366Tryptik CC Anterior Intersomatic Cervical CageSpineart20125—
+4K121567Oracle Lumbar Intervertebral Body Fusion Cage SystemAccel Spine20125—
+4K122021Sterispine LC CageSafe Orthopaedics20122—
+4K121096Venus Lumbar Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd.201236—
+4K120966Depuy Pulse Lumbar Cage SystemMedos International SARL201225—
+4K120203TM-400 DeviceZimmer Trabecular Metal Technology, Inc.201220—
+4K120517Depuy Pulse Cervical Cage SystemMedos International SARL20123—
+4K120063Venus Lumbar Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd.201237—
+4K112696Twin Peaks Lumbar CageQualgenix, LLC20120—
+4K120576Zavation Ibf SystemZavation, LLC201232—
+4K111820Synster Cervical Cage, Alif Cage, Plif Cage, Ptlif Cage, Tlif CageBm Korea Co., Ltd.201220—
+4K113478Plif CageEisertech, LLC2012269—
+4K120024Mectalif TransforaminalMedacta International S.A.201223—
+4K111726Pathway AvidCustom Spine, Inc.201295—
+4K112862Mecta-CMedacta International201114—
+4K111119Trabecular Metal (TM) Fusion DeviceZimmer Spine, Inc.201152—
+4K112444Anatomic Peek Cervical Fusion SystemMedtronic Sofamor Danck USA, Inc.2011324—
+4K112359Prow FusionNlt Spine, Ltd.2011601—
+4K111264Cornerstone (R) PSR Cervical Fusion SystemMedtronic Sofamor Danek USA2011331—
+4K110694Concorde Bullet Spinal SystemJohnson & Johnson2011227—
+4K102315Staxx XDL SystemSpine Wave, Inc.20113—
+4K110915Cervical CageEisertech, LLC201123—
+4K111774Pathway Model 07XXXXCustom Spine201115—
+4K111469Staxxsd SystemSpine Wave, Inc.20110—
+4K111835Plateau Spacer SystemLife Spine, Inc.2011120—
+4K110864Biospine VBR SystemAesculap Implant Systems, LLC201149—
+4K110927MectalifMedacta International2011301
+4K110454Cougar LS Lateral Cage SystemJohnson & Johnson2011602—
+4K111056Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.2011151
+4K102606Avs Anchor-C Cervical Cage SystemStryker Spine20113841
+4K103488Concorde Bullet Cage SystemJohnson and Johnson201129—
+4K102597Piccolo Composite Plate SystemN.M.B. Medical Applications, Ltd.201115—
+4K102369Piccolo Composite Nailing SystemN.M.B. Medical Applications, Ltd.2011161
+4K102322Stingray Cervical Cage; Shark Implant (Plif); Bull Shark Implant (Plif); Tiger Implant…Omni Surgical, L.P.20116—
+4K101923Concorde Curve SystemDepuy Spine2010609—
+4K093093Small Plateau Spacer SystemLife Spine2010393—
+4K100037Advanced Vertebral Solutions Express BFDAdvanced Vertebral Solutions, LLC20100—
+4K100820Wenzel Spine Varilift Interbody Fusion SystemWenzel Spine201016—
+4K100889Endoskeleton TCTitan Spine, LLC2010455—
+4K100802Aesculap Implant Systems Sibd Spinal SystemAesculap Implant Systems, Inc.2010461—
+4K100497Quantum IM Composite Nailing System (Quantum Nailing System)N.M.B. Medical Applications, Ltd.201029—
+4K100043Coroent XLR Standalone SystemNuvasive, Inc.2010744—
+4K093242Patriot Transcontinental Llif SpacerGlobus Medical, Inc.2009921—
+4K091301Life Spine Stand-Alone Spacer SystemLife Spine2009473—
+4K090315Staxx XD SystemSpine Wave, Inc.20096—
+4K082270Octane Vertebral Body Replacement (VBR) SystemVertiflex, Inc.200855—
+4K073177Pioneer Intervertebral Fusion Device SystemPioneer Surgical Technology20087751
+4K080401Shell Cage, Wave Cage, Loop CageAdvanced Medical Technologies AG2008840—
+4K073291Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.20081,103—
+4K080083Intrepid Spinal SystemMedtronic Sofamor Danek20089328
+4K073502Vertebron VBR SystemVertebron, Inc.200812—
+4K043405Nuvasive Coroent SystemNuvasive, Inc.20057121
+5K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+5K261408SABER-XA SystemElevation Spine20260—
+5K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+5K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—