510(k) Report

Devices descending from K083661

757 later devices reach Avs TL Peek Spacers through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K181030Rubicon Lumbar Interbody Fusion SystemRubicon Spine, LLC20180—
+1K143572Intersomatic Cervical Device - DICOM PEEK, Intersomatic Intervertebral Space Maintenance…Osteomed Implantes, Ltda20150—
+1K143163AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK Spacer…Stryker Corporation2015636—
+1K141443Infront Lumbar Interbody Fusion SystemInfront Medical, LLC20142—
+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—
+1K111792Mobis, Moval, Semial, Tetrismodel Peek and Titanium, Kimba Model Standard and MiniSignus Medizintechnik GmbH2012470—
+1K110783Venus Interbody Fixation System- Venus Plif/Tlif, Alif Peek CageL&K BIOMED Co., Ltd.201138—
+1K103814Pezo Interbody Cages SystemUlrich GmbH & Co. KG20114—
+1K101051Avs a-Lat Peek Spacers, Models 48750XXX, 48751XXX, 48752XXX, 48753XXXStryker Spine2010641—
+1K100865Ava Navigator Peek Spacers, Model 48392XXX, 48393XXXStryker Spine2010637—
+1K092017Pivotec Lumbar Interbody Fusion Device (Lifd)Captiva Spine, Inc.200924—
+2K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+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—
+2K191537eCarbon IBDsBack 2 Basics Direct, LLC20193—
+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—
+2K181702Tranquil-L Interbody SystemNexus Spine, LLC20188—
+2K172480icotec Interbody Cage SystemIcotec AG20185—
+2K171140Matrixx SystemNexxt Spine, LLC2017145—
+2K170297Tranquil Interbody SystemNexus Spine, LLC201715—
+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
+2K152620Spine Wave Gen II Expandable Interbody SystemSpine Wave, Inc.20162—
+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—
+2K132894Optio-C Anterior Cervical SystemZimmer Spine, Inc.201424—
+2K123758Tasmin RSignus Medizintechnik GmbH20141—
+2K133126K7 Lumbar SpacersK7, LLC20131—
+2K131077Life Spine Plateau Spacer SystemLife Spine201310—
+2K131372Mobis IISignus Medizintechnik GmbH2013462—
+2K122957Tezo Titanium Cage FamilyUlrich GmbH & Co. KG20130—
+2K122872Intervertebral Body Fusion DeviceDio Medical Co., Ltd.201316—
+2K122518Synster (Cervical,Alif, Plif, Ptlif and Tlif) Cage Hera Cervical Cage Rhea Plif Cage…Bm Korea Co., Ltd.20133—
+2K122956Fuselox Lumbar Interbody Fusion DeviceCaptiva Spine20122—
+2K122444Cervical CageEisertech, LLC201222—
+2K122317Tetris IISignus Medizintechnik GmbH20122—
+2K100743Atlas Spine Pivoting SystemAtlas Spine, Inc.20104—
+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—
+3K243816Testa TP Pivoting Spacer SystemSpine Wave, Inc.20250—
+3K241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc.20241—
+3K242829BluEX Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20240—
+3K241438Signus Tetris™ St; Signus Tetris™ R StSignus Medizintechnik GmbH20240—
+3K232792icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec…Icotec AG20240—
+3K233375Tranquil-L Interbody SystemNexus Spine, LLC20240—
+3K240416Tranquil-C Interbody SystemNexus Spine, LLC20243—
+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—
+3K222806Kodiak C Spinal Implant SystemMet One Technologies, LLC20221—
+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—
+3K214047EL CAPITAN Anterior Lumbar Interbody Fusion SystemAstura Medical20223—
+3K202266Reliance Cervical IBF SystemReliance Medical Systems, LLC20223—
+3K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20227—
+3K210573Velofix SA Cervical CageU&I Corporation20211—
+3K210470C-CURVE Interbody Fusion DeviceMedicrea International SA20210—
+3K201671A-Link ZAcuity Surgical Devices, LLC202125—
+3K210359Hexanium TLIFSpinevision, S.A.S.20211—
+3K203531XYPAN Expandable Lumbar Cage SystemAegis Spine, Inc.20213—
+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—