510(k) Report

Devices descending from K093704

713 later devices reach Avs PL Peek Spacers through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K152200SurgTech Interbody SystemSurgtech, Inc.20160—
+1K143163AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK Spacer…Stryker Corporation2015636—
+1K140564BN Lumbar Cage SystemMedyssey USA, Inc.20143—
+1K130506Imse P-TlifInstitute of Musculoskeletal Science & Education20130—
+1K122518Synster (Cervical,Alif, Plif, Ptlif and Tlif) Cage Hera Cervical Cage Rhea Plif Cage…Bm Korea Co., Ltd.20133—
+1K121254Camber Spine Technologies TLS 5.0 Inerbody CageCamber Spine Technologies201340—
+1K121567Oracle Lumbar Intervertebral Body Fusion Cage SystemAccel Spine20125—
+1K121096Venus Lumbar Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd.201236—
+1K120345Honour Spacer SystemNexxt Spine, LLC2012212—
+1K120063Venus Lumbar Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd.201237—
+1K111820Synster Cervical Cage, Alif Cage, Plif Cage, Ptlif Cage, Tlif CageBm Korea Co., Ltd.201220—
+1K110783Venus Interbody Fixation System- Venus Plif/Tlif, Alif Peek CageL&K BIOMED Co., Ltd.201138—
+1K100865Ava Navigator Peek Spacers, Model 48392XXX, 48393XXXStryker Spine2010637—
+2K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+2K213441PathLoc Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20222—
+2K212389Advantage Lumbar System - ALIF, PLIF, DLIF, TLIFIntelivation, LLC20210—
+2K192863MONDRIAN Lumbar Interbody Fusion Cage SystemCtl Medical Corporation20203—
+2K201585Monterey AL Interbody SystemStryker Corporation202044
+2K192492EL CAPITAN Anterior Lumber Interbody SystemAstura Medical, LLC202010—
+2K193412NEXXT MATRIXX SystemNexxt Spine, LLC20201—
+2K1803473d CageFims Co., Ltd.20190—
+2K190708AccelFix Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20195—
+2K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC201993—
+2K181357PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc.201897—
+2K181963ostaPek Interbody Fusion CagesColigne AG20181—
+2K181591Fixated Asfora BULLET CAGE® (FABC)Medical Designs, LLC20180—
+2K180071STYLO Interbody Fusion DeviceLegend Spine Technologies20180—
+2K170389TAURUS PEEK Cage SystemMedyssey USA, Inc.20170—
+2K172756Varian cageMedyssey USA, Inc.20171—
+2K172419Velofix™ TLIF CageU&I Corporation20172—
+2K172064Ti-Diagon Oblique TLIFCamber Spine Technologies201727—
+2K171140Matrixx SystemNexxt Spine, LLC2017145—
+2K160976Altus Spine Interbody Fusion SystemAltus Partners, LLC20178—
+2K153665Prow Fusion-LNlt Spine, Ltd.20160—
+2K153782NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated2016390—
+2K151665SUSTAIN Additional ImplantsGlobus Medical, Inc.2016119—
+2K151726AVS AL and AVS ALign PEEK Spacers, AVS PL and AVS UniLIF PEEK Spacers, AVS TL PEEK…Stryker Corporation20161391
+2K151773CONCORDE Bullet Lumbar Interbody SystemMedos International SARL2015201—
+2K152304Tritanium PL CageStryker20154481
+2K150788Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral Body Fusion…Meditech Spine, LLC2015202—
+2K151140LnK Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.201529—
+2K143616AccuLIF TL and PL CageStryker Corporation20154694
+2K133827A-Link ZOsteo Vasive, LLC2014262
+2K141376Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx, Struxxure Anterior…Nexxt Spine, LLC2014106—
+2K132483Innesis Peek Cervical CageBk Meditech, Co., Ltd.20140—
+2K133529Camber Spine Coveris Cervical CageCamber Spine201410—
+2K134038Camber Spine Diagon Oblique CageCamber Spine201428—
+2K132894Optio-C Anterior Cervical SystemZimmer Spine, Inc.201424—
+2K131077Life Spine Plateau Spacer SystemLife Spine201310—
+2K122872Intervertebral Body Fusion DeviceDio Medical Co., Ltd.201316—
+2K122444Cervical CageEisertech, LLC201222—
+3K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+3K253151Fule Interbody Fusion Cage SystemBeijing Fule Science & Technology Development Co., Ltd.20260—
+3K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+3K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc.20251—
+3K251741PathLoc Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20250—
+3K241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc.20241—
+3K242829BluEX Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20240—
+3K230478Acro Composites Interbody SystemAcro Composites, LLC20230—
+3K232481RIGEL™ 3DR Anterior Cervical Corpectomy SystemMiRus, LLC20230—
+3K231680AccelFix Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20231—
+3K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+3K222015Integral Titanium Cervical InterbodyNvision Biomedical Technologies, Inc.20231—
+3K220513NITRO Interbody Fusion Cage System FamilyCtl Medical Corporation20230—
+3K222554EL CAPITAN Anterior Lumbar Interbody FusionAstura Medical20235—
+3K221162UniVy OsteoVy Cervical IBF SystemVy Spine, LLC20222—
+3K213641MONDRIAN ALIF Cage with Supplementary Fixation PlateCtl Medical Corporation20221—
+3K221844TDM Lumbar Interbody Fusion Cage SystemTdm Co., Ltd.20221—
+3K213791Unispace SA Cervical CageEdisoninno Co., Ltd.20222—
+3K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+3K213420WaveForm L System, WaveForm TO System, WaveForm TA SystemSeaSpine Orthopedics Corporation202211—
+3K214047EL CAPITAN Anterior Lumbar Interbody Fusion SystemAstura Medical20223—
+3K202266Reliance Cervical IBF SystemReliance Medical Systems, LLC20223—
+3K212904SeaSpine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202115—
+3K213359SeaSpine WaveForm, C Interbody SystemSeaSpine Orthopedics Corporation20217—
+3K210573Velofix SA Cervical CageU&I Corporation20211—
+3K210470C-CURVE Interbody Fusion DeviceMedicrea International SA20210—
+3K210595SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar SpacersCamber Spine Technologies, LLC20213—
+3K201671A-Link ZAcuity Surgical Devices, LLC202125—
+3K210359Hexanium TLIFSpinevision, S.A.S.20211—
+3K203531XYPAN Expandable Lumbar Cage SystemAegis Spine, Inc.20213—
+3K203327VERTACONNECT TLIF CageSignus Medizintechnik20210—
+3K203683CarboClear Lumbar Cage SystemCarbofix Orthpedics, Ltd.20211—
+3K193000Hexanium® ACIFSpinevision, S.A.S.202014—
+3K201506Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical…Meditech Spine, LLC20200—
+3K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC202025—
+3K200969NEXXT MATRIXX SystemNexxt Spine, LLC20200—
+3K192145Galileo Vertebral Body Replacement DeviceBright Spine20201—
+3K200543NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) SystemNexxt Spine, LLC202072—
+3K193378CarboClear Lumbar Cage SystemCarboFix Orthopedics, Ltd.20202—
+3K193370Nexxt Matrixx SystemNexxt Spine, LLC20202—
+3K192115SABLE Expandable SpacerGlobus Medical, Inc.202037—
+3K192687TrellOss™-L MPFNexxt Spine, LLC20201—
+3K192497EVOL ha - D Lateral Interbody Fusion SystemCutting Edge Spine, LLC20201—
+3K191796Neo Cage SystemNeo Medical SA20190—
+3K192026Peridot Intervertebral body fusion SystemGbs Commonwealth Co., Ltd.20196—
+3K192248Cortina™ [MAX] Lumbar Cage SystemNeurostructures, Inc.20190—
+3K191391HEDRON Lumbar SpacersGlobus Medical, Inc.201984—
+3K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer…Choice Spine, LLC20194—
+3K183249Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved…Stryker Spine20196—