510(k) Report

Devices descending from K012254

2,058 later devices reach VBR through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K192117Small VBR™Ulrich GmbH & Co. KG20196—
+1K181921Solidity Vertebral Body ReplacementUlrich Medical USA20182—
+1K181328T2 STRATOSPHERE™ Expandable Corpectomy SystemMedtronic Sofamor Danek USA, Inc.201828—
+1K180673Normandy VBR SystemZavation Medical Products, LLC20187—
+1K173800Camber Spine Technologies SPIRA - V™ Open Matrix Corpectomy CageCamber Spine Technologies20180—
+1K170055CAPRI Corpectomy Cage SystemK2m201711—
+1K151538NuVasive PEEK Corpectomy Railed SystemNu Vasive, Incorporated201513—
+1K151167NuVasive PEEK Corpectomy SystemNu Vasive, Incorporated201513—
+1K142205NuVasive X-CORE (R) Expandable VBR SystemNuvasive, Inc.201574—
+1K140563Lateral VBR SystemNu Vasive, Incorporated20140—
+1K133802Ais Modulift VBR SystemAesculap Implant System, Inc.201448—
+1K112429Giza (R) Vertebral Body ReplacementEden Spine, LLC201221
+1K110864Biospine VBR SystemAesculap Implant Systems, LLC201149—
+1K090841AddplusUlrich GmbH & Co. KG2009215—
+1K070786X-Pod Adjustable Vertebral Body ReplacementTheken Spine, LLC20070—
+1K060416Obelisc Vertebral Body Replacement DeviceUlrich GmbH & Co. KG200656—
+1K053080Graftcage AcxOsteotech, Inc.20050—
+1K021791Verte-Stack Spinal SystemMedtronic Sofamor Danek20022,047—
+2K261031Poseidon STSignus Medinzintechnik GmbH20260—
+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—
+2K193506NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR SystemNu Vasive, Incorporated20201—
+2K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+2K190349MediExpand TL Expandable VBR SystemCmf Medicon Surgical, Inc.20190—
+2K192214CarboClear VBR SystemCarboFix Orthopedics, Ltd.20191—
+2K191423Normandy VBR SystemZavation Medical Products, LLC20193—
+2K183510T2 STRATOSPHERE Expandable Corpectomy SystemMedtronic Sofamor Danek USA, Inc.201927—
+2K183071VLIFT-s Vertebral Body Replacement SystemStryker Spine20194—
+2K180665SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage SystemK2m, LLC20189—
+2K172032Modulift Vertebral Body Replacement (VBR) SystemAesculap Implants Systems, Inc.201746—
+2K171704CAPRI Corpectomy Cage SystemK2m201710—
+2K170271NuVasive (r) Monolith Corpectomy SystemNu Vasive, Incorporated201712—
+2K151651NuVasive X-CORE Mini Cervical Expandable VBR SystemNu Vasive, Incorporated201568—
+2K142016CAPRIK2m, Inc.201412—
+2K142150Ais Modulift VBR SystemAesculap Implant System, Inc.201447—
+2K121107Fortify Integrated Corpectomy Spacers, (Fortify I and Fortify I-R)Globus Medical, Inc.2012214—
+2K081383Reliance VBS SystemReliance Medical Systems, LLC20080—
+2K063637Reliance VBS SystemReliance Medical Systems, LLC20071—
+2K052261Modification to: Verte-Stack Spinal SystemMedtronic Sofamor Danek USA, Inc.2005839—
+2K050809CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2005870—
+2K042201Novel VBR Spinal SystemAlphatec/Nexmed2004796—
+2K041452Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2004815—
+2K033109Ellys and Aurys Vertebral Body ReplacementsScient'X20041,218—
+2K031780Verte-Stack Spinal SystemMedtronic Sofamor Danek20031,326—
+2K030735Modified Verte-Stack Spinal SystemMedtronic Sofamor Danek2003816—
+2K030736Verte-Stack Spinal System, Extra Small SizesMedtronic Sofamor Danek20031,101—
+2K030601Verte-Stack Spinal SystemMedtronic Sofamor Danek20031,151—
+2K023570Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek20021,383—
+3K252686EffortMed PEEK Cages & Corpectomy CagesEffortmed, LLC20251—
+3K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+3K241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc.20241—
+3K241164IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic)202412
+3K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AG20240—
+3K222874CarboClear Cervical Cage System, CarboClear Cervical VBR SystemCarbofix Orthpedics, Ltd.20230—
+3K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+3K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+3K212126MediExpand Cervical Expandable VBR SystemCmf Medicon Surgical, Inc.20220—
+3K211320CAPRI Corpectomy Cage SystemK2m, Inc.20222—
+3K202637F3D Corpectomy SystemCorelink, LLC20201—
+3K193412NEXXT MATRIXX SystemNexxt Spine, LLC20201—
+3K190284Bengal Stackable Cage SystemMedos International SARL20190—
+3K191066CD Horizon™ Astute™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201921—
+3K182928CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201953—
+3K180550NuVasive Monolith Cervical Corpectomy SystemNu Vasive, Incorporated201811—
+3K171848FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO…Globus Medical, Inc.201755—
+3K162315FORTIFY Corpectomy SpacersGlobus Medical, Inc.201755—
+3K162133VerteFIT Corpectomy Cage SystemLdr Spine USA, Inc.20170—
+3K152022SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION®…Globus Medical, Inc.2017149—
+3K143578SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers…Globus Medical, Inc.2016210—
+3K152568C-VBRCardinal Spine, LLC201657—
+3K131082Interform Interbody Cage SystemNext Orthosurgical2013595—
+3K111294Santorini Spinal SystemK2m, Inc.201218—
+3K110562Telamon Peek Spinal SystemMedtronic Sofamor Danek USA2011306—
+3K094025Crescent Spinal SystemMedtronic Sofamor Danek2010838—
+3K090353Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek2009796—
+3K091974Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20096561
+3K082236CD Horizon Spinal SystemMedtronic Sofamor Danek2008779—
+3K073562Modification to Viper Spine SystemDepuy Spine, Inc.2008213—
+3K063670Modifications to CD Horizon Spinal SystemMedtronic Sofamor Danek2007821—
+3K060762Aesculap Peek Vertebral Body Replacement SystemAesculap, Inc.2006789—
+3K061752Spinal Usa VBR SystemSpinal USA20060—
+3K061938Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc.2006152—
+3K061915CD Horizon Spinal SystemMedtronic Sofamor Danek200654—
+3K060719Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2006992—
+3K052170Seaspine VBR SystemSeaspine, Inc.200513—
+3K052931Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2005993—
+3K052747Modification to:CD Horizon Spinal SystemMedtronic Sofamor Danek2005528—
+3K052609Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek200554—
+3K052187Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005780—
+3K051674CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2005587—
+3K043479MC+ Partial VBRLdr Spine USA20051,214—
+3K050348CO Vertebral Body ReplacementScient'X20052—
+3K050624Stryker Spine Avs PL Peek SpacerStryker Spine2005892—
+3K042571Stryker Spine Avs TL Peek SpacerStryker Spine2005894—
+3K043566Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2005726—
+3K042713Fidji-Vertebral Body Replacement Type 5Spine Next America Corporation20040—
+3K042714Fidji-Vertebral Body Replacement Type 1, 2, 3 and 4Spine Next America Corporation2004838—
+3K041197Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2004994—
+3K040731Stryker Spine Vertebral SpacerStryker Spine2004895—