510(k) Report

Devices descending from K051205

829 later devices reach Stryker Spine Avs Asl Peek Spacer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K060762Aesculap Peek Vertebral Body Replacement SystemAesculap, Inc.2006789—
+1K061836Avs Asl Peek Spacer SystemStryker Spine2006213—
+2K151056Aesculap T-Space PEEK and XP Spinal SystemAesculap Implant Systems, LLC20150—
+2K120345Honour Spacer SystemNexxt Spine, LLC2012212—
+2K083311Aesculap Cespace Peek Intervertebral Body Fusion SystemAesculap Implant Systems, Inc.2009554—
+2K071983Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace, Prospace, T-SpaceAesculap Implant Systems, Inc.20087881
+3K193412NEXXT MATRIXX SystemNexxt Spine, LLC20201—
+3K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC201993—
+3K181899Roccia® PlifSilony Medical GmbH20180—
+3K181970MectaLIF Posterior ExtensionMedacta International S.A.20182—
+3K172185Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20177—
+3K171140Matrixx SystemNexxt Spine, LLC2017145—
+3K151408LOSPA IS Spinal SystemCorentec Co., Ltd.20151—
+3K143450Ackermann Intervertebral Body Fusion DeviceAckermann Instrumente GmbH20150—
+3K133827A-Link ZOsteo Vasive, LLC2014262
+3K141376Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx, Struxxure Anterior…Nexxt Spine, LLC2014106—
+3K132852Peek Cage for the Vertebral SpineNeoortho Produtos Ortopedicos S/A20140—
+3K133529Camber Spine Coveris Cervical CageCamber Spine201410—
+3K132421Aesculap Peek XP Spinal Implant SystemAesculap Implant Systems, Inc.201414—
+3K132894Optio-C Anterior Cervical SystemZimmer Spine, Inc.201424—
+3K130573Tyber Medical Interbody System; Acif, Alif, Plif, Tlif, DlifTyber Medical, LLC2013251—
+3K131077Life Spine Plateau Spacer SystemLife Spine201310—
+3K122588Vusion CS PlusOrtho Development Corp.2013206—
+3K123909Aesculap Cespace XPAesculap Implant System, Inc.20137—
+3K122444Cervical CageEisertech, LLC201222—
+3K111820Synster Cervical Cage, Alif Cage, Plif Cage, Ptlif Cage, Tlif CageBm Korea Co., Ltd.201220—
+3K113478Plif CageEisertech, LLC2012269—
+3K112862Mecta-CMedacta International201114—
+3K110915Cervical CageEisertech, LLC201123—
+3K110864Biospine VBR SystemAesculap Implant Systems, LLC201149—
+3K100889Endoskeleton TCTitan Spine, LLC2010455—
+3K100802Aesculap Implant Systems Sibd Spinal SystemAesculap Implant Systems, Inc.2010461—
+4K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+4K251016MectaLIF 3D MetalMedacta International S.A.20250—
+4K241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc.20241—
+4K240838Spectrum Spine Cervical Cage SystemSpectrum Spine, Inc.20244—
+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—
+4K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+4K202266Reliance Cervical IBF SystemReliance Medical Systems, LLC20223—
+4K212831MectaLIF ExtensionMedacta International S.A.20211—
+4K210470C-CURVE Interbody Fusion DeviceMedicrea International SA20210—
+4K201671A-Link ZAcuity Surgical Devices, LLC202125—
+4K210359Hexanium TLIFSpinevision, S.A.S.20211—
+4K193000Hexanium® ACIFSpinevision, S.A.S.202014—
+4K201367FlareHawk TiHawk9 Interbody Fusion SystemIntegrity Implants, Inc.20202—
+4K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC202025—
+4K200969NEXXT MATRIXX SystemNexxt Spine, LLC20200—
+4K193457AUDERE Lumbar Spacer SystemMet One Technologies20201—
+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—
+4K1803473d CageFims Co., Ltd.20190—
+4K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer…Choice Spine, LLC20194—
+4K191408Nexxt Matrixx SystemNexxt Spine, LLC20190—
+4K183092Kuros TLIF CageKuros Biosciences B.V20190—
+4K182284Tyber Medical PT Interbody SpacerTyber Medical, LLC20195—
+4K181589Curiteva Lumbar Interbody Fusion SystemCuriteva, LLC20186—
+4K181435ATEC Cervical Spacer SystemAlphatec Spine, Inc.2018100—
+4K181115CxHA PEEK Cervical IBF SystemInnovasis, Inc.20188—
+4K181261Curiteva Cervical Interbody Fusion SystemCuriteva, LLC20184—
+4K180590Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20186—
+4K172480icotec Interbody Cage SystemIcotec AG20185—
+4K173347STALIF C FLX, STALIF M FLX, STALIF L FLX and STALIF Lateral-Oblique FLX, ACTILIF C FLX…Centinel Spine, Inc.201812—
+4K173082Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20185—
+4K173077Cavetto-SA Cervical Cage SystemNeurostructures, Inc.201821—
+4K172032Modulift Vertebral Body Replacement (VBR) SystemAesculap Implants Systems, Inc.201746—
+4K172446SPIRA-C Open Matrix Cervical InterbodyCamber Spine Technologies20176—
+4K171914Cortina™ Lumbar Cage SystemNeurostructures, Inc.20172—
+4K172587Mecta-C with titanium markers and Mecta-C TiPEEK with titanium markersMedacta International S.A.20170—
+4K170550Coveris Cervical Cage SystemCamber Spine Technologies20171—
+4K170503EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular…Eit Emerging Implant Technologies GmbH20171992
+4K170844Gemini-C Hybrid Cervical Interbody SystemOsseus Fusion Systems, LLC20170—
+4K170243LOSPA IS TLIF & DLIF CagesCorentec Co., Ltd.20170—
+4K162693VertebraLINK Fusion PlatformFacetlink Dba Linkspine20170—
+4K1624024CIS® Marlin ACIF Cage SystemSolco Biomedical Co., Ltd.20171—
+4K161127The Small PLATEAU (PLATEAU-C) Spacer SystemLife Spine, Inc.20166—
+4K162003IMSE Cervical CageThe Institute of Musculoskeletal Science & Education20160—
+4K161809ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc.20165—
+4K160699VIRTU Lumbar Spacer SystemMet 1 Technologies, LLC20162—
+4K160154ALTA Anterior Cervical Interbody SpacerAstura Medical201663—
+4K160522White Pearl Preferred Angle Anterior Cervical PlateOsseus Fusion Systems, LLC20160—
+4K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+4K152200SurgTech Interbody SystemSurgtech, Inc.20160—
+4K153356Spine Innovation Interbody SystemSpine Innovation, LLC20161—
+4K150847Foundation Interbody DevicesCorelink, LLC201529—
+4K142744Mecta-C TiPEEKMedacta International201512—
+4K140348Interbody CageEisertech, LLC2015235—
+4K142940Endoskeleton TCS SystemTitan Spine, LLC20151112
+4K141333Arena-C Tifuse Cervical Intervertebral Body Fusion DeviceSpinefrontier, Inc.20140—
+4K142150Ais Modulift VBR SystemAesculap Implant System, Inc.201447—
+4K141953Endoskeleton; TA Ibd and VBR, to and TT, Tas, TC, TLTitan Spine, LLC20142652
+4K142589Endoskeleton TA IBD and VBR, Endoskeleton TO and TT, Endoskeleton TAS, Endoskeleton TAS…Titan Spine, LLC2014106—
+4K133717Longbow Spacer SystemLife Spine20149—
+4K133802Ais Modulift VBR SystemAesculap Implant System, Inc.201448—
+4K132738Cogent Med-LifCogent Spine, LLC201413—
+4K132483Innesis Peek Cervical CageBk Meditech, Co., Ltd.20140—