510(k) Report

Devices descending from K011037

1,374 later devices reach Vertebral Spacer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K081383Reliance VBS SystemReliance Medical Systems, LLC20080—
+1K072981Synthes Zero-PSynthes Spine Co.Lp20085462
+1K070218Vertiflex Octane Peek Vertebral Body Replacement (Peek VBR)Vertiflex (Tm), Incorporated200760—
+1K062083Synfix -LRSynthes Spine Co.Lp20071,252—
+1K062933Synthes Oracle SpacerSynthes Spine Co.Lp2007600—
+1K053508Synfix-LRSynthes Spine Co.Lp2006391
+1K051781Graftcage TLXOsteotech, Inc.20050Class I
+1K051205Stryker Spine Avs Asl Peek SpacerStryker Spine2005829—
+1K043405Nuvasive Coroent SystemNuvasive, Inc.20057121
+1K042713Fidji-Vertebral Body Replacement Type 5Spine Next America Corporation20040—
+1K042714Fidji-Vertebral Body Replacement Type 1, 2, 3 and 4Spine Next America Corporation2004838—
+2K253213SAGI Cervical Cage SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+2K172424Velofix™ SA Cervical CageU&I Corporation201751
+2K153250Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies201632—
+2K152532AERO -C Cervical Cage SystemStryker Spine2015145—
+2K151408LOSPA IS Spinal SystemCorentec Co., Ltd.20151—
+2K150673SYNFIX Evolution Secured Spacer SystemSynthes (USA) Products, LLC2015137—
+2K141187Impix Alif S/aMedicrea International SA201501
+2K132907Plif Lite and Tlif LiteSintea Plustek20140—
+2K131082Interform Interbody Cage SystemNext Orthosurgical2013595—
+2K121567Oracle Lumbar Intervertebral Body Fusion Cage SystemAccel Spine20125—
+2K121096Venus Lumbar Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd.201236—
+2K120275Synthes Acis/Vertebral Spacer CRSynthes (Usa), LLC2012173—
+2K113796Solitaire-C Cervical Spacer SystemEbi, LLC20121421
+2K120031Chesapeake Spinal SystemK2m, Inc.2012334—
+2K112459Synthes Zero-PSynthes Spine Co.Lp2011277—
+2K112068Synthes Zero-P Variable Angle (VA)Synthes Spine Co.Lp2011331
+2K110783Venus Interbody Fixation System- Venus Plif/Tlif, Alif Peek CageL&K BIOMED Co., Ltd.201138—
+2K103320Synthes XRLSynthes Spine Co.Lp201131
+2K102315Staxx XDL SystemSpine Wave, Inc.20113—
+2K100698STCCCardinal Spine, LLC2011346—
+2K102547Coroent Interlock SystemNuvasive, Inc.2011131—
+2K093762Synthes Zero-PSynthes Spine20103061
+2K101363VU Cpod Intervertebral Bodu Fusion DeviceMusculoskeletal Clinical Regulatory Advisers201078—
+2K092521ZUMA-CSeaspine, Inc.2010168—
+2K092211Chesapeake Spinal SystemK2m, Inc.2010450—
+2K082270Octane Vertebral Body Replacement (VBR) SystemVertiflex, Inc.200855—
+2K071726ZUMASeaspine, Inc.200712—
+2K072253Synfix-LR SpacerSynthes Spine Co.Lp20071,2501
+2K060762Aesculap Peek Vertebral Body Replacement SystemAesculap, Inc.2006789—
+2K061836Avs Asl Peek Spacer SystemStryker Spine2006213—
+2K052210Nuvasive Coroent Extensure SystemNuvasive, Inc.2005263—
+2K051454Aleutian Spacer SystemK2m, LLC2005666—
+2K051246Construx Mini Peek VBR SystemBlackstone Medical, Inc.2005834—
+3K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+3K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+3K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc.20251—
+3K231739Cervical Spine Truss System (CSTS)4Web Medical, Inc.20232—
+3K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+3K220296Manta Ray TDF SpacerSeaSpine Orthopedics Corporation20231—
+3K223105Tesera-K SC SystemKyocera Medical Technologies, Inc.20225—
+3K213791Unispace SA Cervical CageEdisoninno Co., Ltd.20222—
+3K213441PathLoc Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20222—
+3K212266FIX-C PEEK Anterior Cervical Interbody SystemJeil Medical Corporation20217—
+3K210573Velofix SA Cervical CageU&I Corporation20211—
+3K212389Advantage Lumbar System - ALIF, PLIF, DLIF, TLIFIntelivation, LLC20210—
+3K200458Tailored-C Cervical Interbody Fusion SystemBespoke Technologies20203—
+3K192863MONDRIAN Lumbar Interbody Fusion Cage SystemCtl Medical Corporation20203—
+3K201585Monterey AL Interbody SystemStryker Corporation202044
+3K200235KONG-TL VBR System, KONG-C VBR SystemIcotec AG20201—
+3K192906Mecta-C Stand AloneMedacta International S.A.20201—
+3K192208CORNICE Cervical Spacer SystemLegend Spine Technologies20190—
+3K190708AccelFix Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20195—
+3K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer…Choice Spine, LLC20194—
+3K183083Shoreline Cervical Interbody RT SystemSeaSpine Orthopedics Corporation201960—
+3K181118Reliance Lumbar IBF SystemReliance Medical Systems20190—
+3K182007Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies20180—
+3K181140Axis Chena Cervical PEEK Spacer SystemAxis Orthopaedics20182—
+3K181963ostaPek Interbody Fusion CagesColigne AG20181—
+3K181621Stable-C Interbody SystemNexus Spine, LLC20187—
+3K181229TirboLOX-C Cervical IBFDCaptiva Spine, Inc.20180—
+3K180695FBC 921 (Alif)Fbc Device Aps20180—
+3K180963Roccia Alif, Roccia TlifSilony Medical GmbH20183—
+3K180364HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC2018106—
+3K180002Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20182—
+3K172320Neurostructures Cavetto® Cervical Cage SystemNeurostructures, Inc.20183—
+3K173077Cavetto-SA Cervical Cage SystemNeurostructures, Inc.201821—
+3K172926SeaSpine Vu cPOD, Zuma-C, Complete CervicalSeaSpine Orthopedics Corporation201761—
+3K172185Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20177—
+3K171496Tritanium C Anterior Cervical CageStryker Spine2017129—
+3K171075Calix-C Cervical Interbody SpacerX-Spine Systems, Inc.201715—
+3K170676HD Lumbar Interbody SystemHd Lifesciences, LLC2017122—
+3K170318NeoFuse Ti3D PLIF/TLIF/Cervical InterbodyHt Medical, LLC201749—
+3K170961NuVasive CoRoent Small Interlock II SystemNu Vasive, Incorporated201718—
+3K163670Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20173—
+3K163481HALF DOME Posterior Lumbar Interbody SystemAstura Medical201731—
+3K170243LOSPA IS TLIF & DLIF CagesCorentec Co., Ltd.20170—
+3K1624024CIS® Marlin ACIF Cage SystemSolco Biomedical Co., Ltd.20171—
+3K162358T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution SystemSynthes USA Products, LLC2016127—
+3K161442NuVasive® CoRoent® Small Interlock™ SystemNu Vasive, Incorporated201694—
+3K152793Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.201629—
+3K152620Spine Wave Gen II Expandable Interbody SystemSpine Wave, Inc.20162—
+3K152460Rectangular Corpectomy CageAmendia, Inc.20150—
+3K151481Sahara Stabilization SystemK2m, Inc.20155—
+3K151140LnK Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.201529—
+3K151056Aesculap T-Space PEEK and XP Spinal SystemAesculap Implant Systems, LLC20150—
+3K151064Solitaire-C Cervical Spacer System, C-Thru Anterior Spinal System, Breckenridge Small…Biomet Spine201517—
+3K151184InFill Interbody Fusion DevicesPinnacle Spine Group, LLC20153—
+3K142487Chesapeake Stabilization SystemK2m, Inc.201571
+3K141665NuVasive CoRoent SystemNuvasive, Inc.2015588—