510(k) Report

Devices descending from K003275

1,705 later devices reach Synthes Synmesh Spacer System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K183054SYNMESH SystemDepuy Synthes Spine20190—
+1K121176STGCCardinal Spine, LLC201259—
+1K103320Synthes XRLSynthes Spine Co.Lp201131
+1K112756Fortify (TM) and Fortify (TM)-R Corpectomy SpacersGlobus Medical, Inc.2011268—
+1K070381Theken VU Mesh VBR SystemTheken Spine, LLC200725—
+1K061578SSP Vertebral Body ReplacementSpecialty Spine Products, LLC20060—
+1K050449Quantum Vertebral Body ReplacementQuantum Orthopedics, Inc.2005197—
+1K041389Synthes Contoured Synmesh SpacerSynthes Spine20042721
+1K032371Titanium Mesh SystemEncore Medical L.P.200426—
+1K031302Sustain SpacerGlobus Medical, Inc.2003911—
+1K030744Blackstone Surgical Titanium MeshBlackstone Medical, Inc.20031,040—
+1K020887Ebi Ais Spine SystemEbi, L.P.20021,622—
+1K020152Synthes Vertebral Spacer TISynthes (Usa)20021,684—
+2K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+2K200235KONG-TL VBR System, KONG-C VBR SystemIcotec AG20201—
+2K190147COLOSSEUM MeshGlobus Medical, Inc.20190—
+2K183197PYRAMESH™ Implant SystemMedtronic Sofamor Danek USA, Inc.20190—
+2K173982FORTIFY Corpectomy SpacersGlobus Medical, Inc.20188—
+2K171848FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO…Globus Medical, Inc.201755—
+2K162315FORTIFY Corpectomy SpacersGlobus Medical, Inc.201755—
+2K172323Omnia Medical VBROmnia Medical, LLC20176—
+2K152022SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION®…Globus Medical, Inc.2017149—
+2K143578SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers…Globus Medical, Inc.2016210—
+2K152568C-VBRCardinal Spine, LLC201657—
+2K152460Rectangular Corpectomy CageAmendia, Inc.20150—
+2K142030STGC-LordoticCardinal Spine, LLC201558—
+2K131292Deroyal Spine Spacer SystemDeroyal Industries, Inc.20140—
+2K130478Sustain and Sustain Radiolucent SpacersGlobus Medical, Inc.2013256—
+2K121107Fortify Integrated Corpectomy Spacers, (Fortify I and Fortify I-R)Globus Medical, Inc.2012214—
+2K111294Santorini Spinal SystemK2m, Inc.201218—
+2K081383Reliance VBS SystemReliance Medical Systems, LLC20080—
+2K072537Creaspine Supstance Vertebral Body Replacement SystemCreaspine Sas20071—
+2K063637Reliance VBS SystemReliance Medical Systems, LLC20071—
+2K063464Atlas Spine Vertebral Body ReplacementAtlas Spine, Inc.20072—
+2K062151Box Peek VBR SystemInnovasis, Inc.2006175—
+2K061752Spinal Usa VBR SystemSpinal USA20060—
+2K052170Seaspine VBR SystemSeaspine, Inc.200513—
+2K051246Construx Mini Peek VBR SystemBlackstone Medical, Inc.2005834—
+2K050850Xpand Corpectomy SpacerGlobus Medical, Inc.2005284—
+2K041798Atalia Titanium Surgical MeshUs Spinal Technologies, LLC20050—
+2K042268Ebi Cas Spine Spacer SystemEbi, L.P.20041,620—
+2K040482Ebi Esl Spine Spacer SystemEbi, L.P.20041,621—
+2K033702Blackstone Peek Vertebral Body Replacement SystemBlackstone Medical, Inc.20041,036—
+2K040284Sustain Radiolucent SpacerGlobus Medical, Inc.2004906—
+2K032812Endoskeleton TA Vertebral Body ReplacementOrthovita, Inc.20035651
+2K032700Blackstone Surgical Titanium Mesh System Angled End RingsBlackstone Medical, Inc.20031—
+2K024364Synthes Vertebral Spacer TI (Curved and Narrow)Synthes (Usa)20031,683—
+3K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AG20240—
+3K232481RIGEL™ 3DR Anterior Cervical Corpectomy SystemMiRus, LLC20230—
+3K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+3K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+3K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+3K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc.202135—
+3K201287Impulse Interbody Fusion SystemDegen Medical20208—
+3K192117Small VBR™Ulrich GmbH & Co. KG20196—
+3K191778Omnia Medical VBROmnia Medical, LLC20195—
+3K183249Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved…Stryker Spine20196—
+3K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+3K183588Choice Spine Hawkeye Vertebral Body Replacement (VBR) SystemChoicespine20195—
+3K182477Cervical SpacerAdditive Implants, LLC201915—
+3K183071VLIFT-s Vertebral Body Replacement SystemStryker Spine20194—
+3K180909REVEL SpacersGlobus Medical, Inc.201837—
+3K181357PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc.201897—
+3K180665SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage SystemK2m, LLC20189—
+3K181591Fixated Asfora BULLET CAGE® (FABC)Medical Designs, LLC20180—
+3K181328T2 STRATOSPHERE™ Expandable Corpectomy SystemMedtronic Sofamor Danek USA, Inc.201828—
+3K173893TrabisColigne AG20180—
+3K180673Normandy VBR SystemZavation Medical Products, LLC20187—
+3K181261Curiteva Cervical Interbody Fusion SystemCuriteva, LLC20184—
+3K173722PATRIOT COLONIAL Spacer, SUSTAIN SpacerGlobus Medical, Inc.201894—
+3K173115COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and…Globus Medical, Inc.201783—
+3K173080IVA Cage Ti (ACIF, PLIF, TLIF, DLIF, and ALIF)Huvexel Co., Ltd.20172—
+3K170157INDEPENDENCE® SpacersGlobus Medical, Inc.2017109—
+3K171704CAPRI Corpectomy Cage SystemK2m201710—
+3K171567IRIX-A Lumbar Integrated Fusion SystemX-Spine Systems, Inc.201701
+3K171075Calix-C Cervical Interbody SpacerX-Spine Systems, Inc.201715—
+3K162133VerteFIT Corpectomy Cage SystemLdr Spine USA, Inc.20170—
+3K170055CAPRI Corpectomy Cage SystemK2m201711—
+3K161223TransContinental® M Spacers and InterContinental® Plate-SpacersGlobus Medical, Inc.2016117—
+3K151665SUSTAIN Additional ImplantsGlobus Medical, Inc.2016119—
+3K151481Sahara Stabilization SystemK2m, Inc.20155—
+3K142218Coalition AGX Plate and Coalition AGX SpacerGlobus Medical, Inc.2015155—
+3K142016CAPRIK2m, Inc.201412—
+3K141953Endoskeleton; TA Ibd and VBR, to and TT, Tas, TC, TLTitan Spine, LLC20142652
+3K142589Endoskeleton TA IBD and VBR, Endoskeleton TO and TT, Endoskeleton TAS, Endoskeleton TAS…Titan Spine, LLC2014106—
+3K140142Choice Spine Lumbar Spacer System (Sabre, Shark, Hornet, Harpoon)Choicespine, LP2014172—
+3K140055Endoskeleton (R) TL Interbody Fusion DeviceTitan Spine, LLC2014267—
+3K133802Ais Modulift VBR SystemAesculap Implant System, Inc.201448—
+3K131350Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc.2013214
+3K122989Biomet Lateral Spacer SystemBiomet Spine (Aka Ebi, LLC)2012171—
+3K121581Box Peek VBR System,Innovasis, Inc.20121—
+3K120345Honour Spacer SystemNexxt Spine, LLC2012212—
+3K112014Zyston Straight Spacer SystemBiomet Spine2011174—
+3K101812Construx Mini Peek Spacer SystemOrthofix, Inc.2010291—
+3K091381Ibex Spinal SystemEbi, L.P.2009181—
+3K081880Atlas Spine SpacerAtlas Spine, Inc.20080—
+3K081849Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc.20087531
+3K081564Creaspine Supstance Vertebral Body Replacement System Line ExtensionCreaspine20080—
+3K080615Endoskeleton TA Interbody Fusion Device (Ibd)Titan Spine, LLC2008564—
+3K071726ZUMASeaspine, Inc.200712—