510(k) Report

Devices descending from K841189

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K192117Small VBR™Ulrich GmbH & Co. KG20196—
+1K181921Solidity Vertebral Body ReplacementUlrich Medical USA20182—
+1K111294Santorini Spinal SystemK2m, Inc.201218—
+1K051205Stryker Spine Avs Asl Peek SpacerStryker Spine2005829—
+1K042571Stryker Spine Avs TL Peek SpacerStryker Spine2005894—
+1K021791Verte-Stack Spinal SystemMedtronic Sofamor Danek20022,047—
+1K020887Ebi Ais Spine SystemEbi, L.P.20021,622—
+1K003043Surgical Titanium Mesh SystemDepuyacromed20011,819—
+1K990148Stackable Cage SystemDepuy Motech Acromed19991,867—
+2K232173Ascend VBR System, Ascend NanoTec VBR SystemAlphatec Spine, Inc.20230—
+2K211892ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages)Arftx Medical, LLC20222—
+2K200235KONG-TL VBR System, KONG-C VBR SystemIcotec AG20201—
+2K173787X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage System…Medos International SARL20182—
+2K171704CAPRI Corpectomy Cage SystemK2m201710—
+2K162133VerteFIT Corpectomy Cage SystemLdr Spine USA, Inc.20170—
+2K170055CAPRI Corpectomy Cage SystemK2m201711—
+2K151481Sahara Stabilization SystemK2m, Inc.20155—
+2K142212Pyrenees Cervical Plate SystemK2m, Inc.20150—
+2K142030STGC-LordoticCardinal Spine, LLC201558—
+2K142016CAPRIK2m, Inc.201412—
+2K121176STGCCardinal Spine, LLC201259—
+2K120345Honour Spacer SystemNexxt Spine, LLC2012212—
+2K093207Enduramesh, Model 762.XXXLucero Medical, LLC201011
+2K092774Atlas Intervertebral Body CageSpinal Edge, LLC20100—
+2K091946Vlift-S Vertebral Body Replacement System, Models 488812XX, 488814XX, 488816XX, 488818XXStryker Spine20095—
+2K090566Pathway AvidCustom Spine, Inc.2009639—
+2K081383Reliance VBS SystemReliance Medical Systems, LLC20080—
+2K081564Creaspine Supstance Vertebral Body Replacement System Line ExtensionCreaspine20080—
+2K080860Creaspine Supstance Small Vertebral Body Replacement SystemCreaspine20080—
+2K080281PathwayCustom Spine, Inc.2008188—
+2K073649Bengal Stackable Cage SystemDepuy Spine, Inc.2008278—
+2K072537Creaspine Supstance Vertebral Body Replacement SystemCreaspine Sas20071—
+2K063637Reliance VBS SystemReliance Medical Systems, LLC20071—
+2K070381Theken VU Mesh VBR SystemTheken Spine, LLC200725—
+2K060762Aesculap Peek Vertebral Body Replacement SystemAesculap, Inc.2006789—
+2K061752Spinal Usa VBR SystemSpinal USA20060—
+2K061836Avs Asl Peek Spacer SystemStryker Spine2006213—
+2K060916Atlas Spinal Cage, Models SC-150-007, 009, 011, 013, 015, 017.Spinal Edge, LLC20061—
+2K060506Stryker Spine Vlift Vertebral Body Replacement SystemStryker Spine2006270—
+2K051781Graftcage TLXOsteotech, Inc.20050Class I
+2K052261Modification to: Verte-Stack Spinal SystemMedtronic Sofamor Danek USA, Inc.2005839—
+2K050809CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2005870—
+2K050058Theken Reveal VBR SystemTheken Surgical,Llc2005727—
+2K050624Stryker Spine Avs PL Peek SpacerStryker Spine2005892—
+2K041798Atalia Titanium Surgical MeshUs Spinal Technologies, LLC20050—
+2K041407Titanium Mesh ImplantInterpore Cross Intl.20040—
+2K042268Ebi Cas Spine Spacer SystemEbi, L.P.20041,620—
+2K042201Novel VBR Spinal SystemAlphatec/Nexmed2004796—
+2K041722Modification to VBR Spinal SystemDepuy Spine, Inc.20041,150—
+2K041617Stalif TTSurgicraft, Ltd.2004929—
+2K040731Stryker Spine Vertebral SpacerStryker Spine2004895—
+2K041452Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2004815—
+2K040482Ebi Esl Spine Spacer SystemEbi, L.P.20041,621—
+2K033109Ellys and Aurys Vertebral Body ReplacementsScient'X20041,218—
+2K032064Theken Cpod/Lpod Vertebral Body Replacement SystemTheken Surgical,Llc20041,2801
+2K032371Titanium Mesh SystemEncore Medical L.P.200426—
+2K032812Endoskeleton TA Vertebral Body ReplacementOrthovita, Inc.20035651
+2K031780Verte-Stack Spinal SystemMedtronic Sofamor Danek20031,326—
+2K031635Depuy Acromed VBR SystemDepuyacromed20031,201—
+2K030735Modified Verte-Stack Spinal SystemMedtronic Sofamor Danek2003816—
+2K030833Depuy Acromed VBR SystemDepuyacromed20031,224—
+2K022793Tetris Spinal ImplantSignus Medical, LLC20031,705—
+2K030736Verte-Stack Spinal System, Extra Small SizesMedtronic Sofamor Danek20031,101—
+2K030601Verte-Stack Spinal SystemMedtronic Sofamor Danek20031,151—
+2K030249Surgical Titanium Mesh SystemDepuyacromed2003616—
+2K023835Devex Mesh SystemDepuyacromed20031,227—
+2K023570Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek20021,383—
+2K020522Modification to Surgical Titanium Mesh SystemDepuyacromed20021,234—
+2K003836Synthes Synex Spacer SystemSynthes20011,33011
+3K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+3K252686EffortMed PEEK Cages & Corpectomy CagesEffortmed, LLC20251—
+3K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AG20240—
+3K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+3K201585Monterey AL Interbody SystemStryker Corporation202044
+3K193412NEXXT MATRIXX SystemNexxt Spine, LLC20201—
+3K190284Bengal Stackable Cage SystemMedos International SARL20190—
+3K192214CarboClear VBR SystemCarboFix Orthopedics, Ltd.20191—
+3K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC201993—
+3K183083Shoreline Cervical Interbody RT SystemSeaSpine Orthopedics Corporation201960—
+3K182928CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201953—
+3K183071VLIFT-s Vertebral Body Replacement SystemStryker Spine20194—
+3K180665SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage SystemK2m, LLC20189—
+3K172926SeaSpine Vu cPOD, Zuma-C, Complete CervicalSeaSpine Orthopedics Corporation201761—
+3K172323Omnia Medical VBROmnia Medical, LLC20176—
+3K171140Matrixx SystemNexxt Spine, LLC2017145—
+3K160631Keos Lumbar IBFDKeos20161—
+3K153400ProLift Expandable SystemLife Spine, Inc.201672—
+3K152568C-VBRCardinal Spine, LLC201657—
+3K151310Amendia Interbody Fusion DevicesAmendia, Inc.2016169—
+3K151352CONCORDE Bullet Spinal SystemMedos International SARL20153—
+3K151056Aesculap T-Space PEEK and XP Spinal SystemAesculap Implant Systems, LLC20150—
+3K142205NuVasive X-CORE (R) Expandable VBR SystemNuvasive, Inc.201574—
+3K133827A-Link ZOsteo Vasive, LLC2014262
+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—
+3K133717Longbow Spacer SystemLife Spine20149—
+3K141443Infront Lumbar Interbody Fusion SystemInfront Medical, LLC20142—
+3K133813Flxfit Intervertebral Body Fusion DeviceExpanding Orthopedics, Inc.2014137—
+3K140055Endoskeleton (R) TL Interbody Fusion DeviceTitan Spine, LLC2014267—
+3K141376Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx, Struxxure Anterior…Nexxt Spine, LLC2014106—