510(k) Report

Devices descending from K040731

895 later devices reach Stryker Spine Vertebral Spacer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K051205Stryker Spine Avs Asl Peek SpacerStryker Spine2005829—
+1K050624Stryker Spine Avs PL Peek SpacerStryker Spine2005892—
+1K042571Stryker Spine Avs TL Peek SpacerStryker Spine2005894—
+2K141443Infront Lumbar Interbody Fusion SystemInfront Medical, LLC20142—
+2K120464Innesis Peek CageBk Meditech, Co., Ltd.20136—
+2K120345Honour Spacer SystemNexxt Spine, LLC2012212—
+2K112014Zyston Straight Spacer SystemBiomet Spine2011174—
+2K060762Aesculap Peek Vertebral Body Replacement SystemAesculap, Inc.2006789—
+2K062132Avs PL Peek Spacer SystemStryker Spine2006243—
+2K061836Avs Asl Peek Spacer SystemStryker Spine2006213—
+2K060506Stryker Spine Vlift Vertebral Body Replacement SystemStryker Spine2006270—
+2K053508Synfix-LRSynthes Spine Co.Lp2006391
+2K051781Graftcage TLXOsteotech, Inc.20050Class I
+3K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+3K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+3K193412NEXXT MATRIXX SystemNexxt Spine, LLC20201—
+3K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC201993—
+3K181030Rubicon Lumbar Interbody Fusion SystemRubicon Spine, LLC20180—
+3K170119Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc.201711
+3K171140Matrixx SystemNexxt Spine, LLC2017145—
+3K151056Aesculap T-Space PEEK and XP Spinal SystemAesculap Implant Systems, LLC20150—
+3K133827A-Link ZOsteo Vasive, LLC2014262
+3K140577Innesis Peek TL CageBk Meditech, Co., Ltd.20142—
+3K141376Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx, Struxxure Anterior…Nexxt Spine, LLC2014106—
+3K123607Octane Elevate Spinal Implant SystemExactech, Inc.20141—
+3K132483Innesis Peek Cervical CageBk Meditech, Co., Ltd.20140—
+3K133529Camber Spine Coveris Cervical CageCamber Spine201410—
+3K132894Optio-C Anterior Cervical SystemZimmer Spine, Inc.201424—
+3K131077Life Spine Plateau Spacer SystemLife Spine201310—
+3K122989Biomet Lateral Spacer SystemBiomet Spine (Aka Ebi, LLC)2012171—
+3K122444Cervical CageEisertech, LLC201222—
+3K110783Venus Interbody Fixation System- Venus Plif/Tlif, Alif Peek CageL&K BIOMED Co., Ltd.201138—
+3K112756Fortify (TM) and Fortify (TM)-R Corpectomy SpacersGlobus Medical, Inc.2011268—
+3K091946Vlift-S Vertebral Body Replacement System, Models 488812XX, 488814XX, 488816XX, 488818XXStryker Spine20095—
+3K083311Aesculap Cespace Peek Intervertebral Body Fusion SystemAesculap Implant Systems, Inc.2009554—
+3K071983Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace, Prospace, T-SpaceAesculap Implant Systems, Inc.20087881
+3K070218Vertiflex Octane Peek Vertebral Body Replacement (Peek VBR)Vertiflex (Tm), Incorporated200760—
+4K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+4K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+4K241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc.20241—
+4K233375Tranquil-L Interbody SystemNexus Spine, LLC20240—
+4K232481RIGEL™ 3DR Anterior Cervical Corpectomy SystemMiRus, LLC20230—
+4K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+4K222015Integral Titanium Cervical InterbodyNvision Biomedical Technologies, Inc.20231—
+4K221162UniVy OsteoVy Cervical IBF SystemVy Spine, LLC20222—
+4K220953ChoiceSpine TigerShark™ M, Modular Interbody SystemChoice Spine, LLC20220—
+4K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+4K202266Reliance Cervical IBF SystemReliance Medical Systems, LLC20223—
+4K213441PathLoc Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20222—
+4K210470C-CURVE Interbody Fusion DeviceMedicrea International SA20210—
+4K201671A-Link ZAcuity Surgical Devices, LLC202125—
+4K203520Blustone Synergy Interbody Fusion SystemBlustone Synergy, LLC20210—
+4K210359Hexanium TLIFSpinevision, S.A.S.20211—
+4K193000Hexanium® ACIFSpinevision, S.A.S.202014—
+4K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC202025—
+4K200969NEXXT MATRIXX SystemNexxt Spine, LLC20200—
+4K192145Galileo Vertebral Body Replacement DeviceBright Spine20201—
+4K200543NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) SystemNexxt Spine, LLC202072—
+4K193370Nexxt Matrixx SystemNexxt Spine, LLC20202—
+4K192687TrellOss™-L MPFNexxt Spine, LLC20201—
+4K190708AccelFix Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20195—
+4K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer…Choice Spine, LLC20194—
+4K191408Nexxt Matrixx SystemNexxt Spine, LLC20190—
+4K190147COLOSSEUM MeshGlobus Medical, Inc.20190—
+4K183071VLIFT-s Vertebral Body Replacement SystemStryker Spine20194—
+4K181899Roccia® PlifSilony Medical GmbH20180—
+4K181970MectaLIF Posterior ExtensionMedacta International S.A.20182—
+4K181963ostaPek Interbody Fusion CagesColigne AG20181—
+4K173982FORTIFY Corpectomy SpacersGlobus Medical, Inc.20188—
+4K181435ATEC Cervical Spacer SystemAlphatec Spine, Inc.2018100—
+4K181115CxHA PEEK Cervical IBF SystemInnovasis, Inc.20188—
+4K173347STALIF C FLX, STALIF M FLX, STALIF L FLX and STALIF Lateral-Oblique FLX, ACTILIF C FLX…Centinel Spine, Inc.201812—
+4K173077Cavetto-SA Cervical Cage SystemNeurostructures, Inc.201821—
+4K172185Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20177—
+4K171848FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO…Globus Medical, Inc.201755—
+4K172756Varian cageMedyssey USA, Inc.20171—
+4K162315FORTIFY Corpectomy SpacersGlobus Medical, Inc.201755—
+4K172446SPIRA-C Open Matrix Cervical InterbodyCamber Spine Technologies20176—
+4K170550Coveris Cervical Cage SystemCamber Spine Technologies20171—
+4K152022SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION®…Globus Medical, Inc.2017149—
+4K162003IMSE Cervical CageThe Institute of Musculoskeletal Science & Education20160—
+4K160522White Pearl Preferred Angle Anterior Cervical PlateOsseus Fusion Systems, LLC20160—
+4K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+4K143578SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers…Globus Medical, Inc.2016210—
+4K151310Amendia Interbody Fusion DevicesAmendia, Inc.2016169—
+4K151408LOSPA IS Spinal SystemCorentec Co., Ltd.20151—
+4K143450Ackermann Intervertebral Body Fusion DeviceAckermann Instrumente GmbH20150—
+4K151140LnK Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.201529—
+4K133717Longbow Spacer SystemLife Spine20149—
+4K132852Peek Cage for the Vertebral SpineNeoortho Produtos Ortopedicos S/A20140—
+4K132421Aesculap Peek XP Spinal Implant SystemAesculap Implant Systems, Inc.201414—
+4K130573Tyber Medical Interbody System; Acif, Alif, Plif, Tlif, DlifTyber Medical, LLC2013251—
+4K122588Vusion CS PlusOrtho Development Corp.2013206—
+4K123909Aesculap Cespace XPAesculap Implant System, Inc.20137—
+4K121567Oracle Lumbar Intervertebral Body Fusion Cage SystemAccel Spine20125—
+4K121096Venus Lumbar Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd.201236—
+4K121107Fortify Integrated Corpectomy Spacers, (Fortify I and Fortify I-R)Globus Medical, Inc.2012214—
+4K120063Venus Lumbar Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd.201237—
+4K111820Synster Cervical Cage, Alif Cage, Plif Cage, Ptlif Cage, Tlif CageBm Korea Co., Ltd.201220—
+4K113478Plif CageEisertech, LLC2012269—