510(k) Report

Devices descending from K080758

1,091 later devices reach Avs PL Peek Spacers, Models 48351 and 48353 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K100865Ava Navigator Peek Spacers, Model 48392XXX, 48393XXXStryker Spine2010637—
+1K090816Stryker Spine Avs PL Peek SpacersStryker Corp.2009756—
+1K081196Spinal Usa VBR SystemSpinal USA200813—
+1K081636Peek-Optima Alif SpacerBiomet Spine2008542—
+1K082014Stryker Spine Avs PL Peek SpacersStryker Corp.2008837—
+1K081395Solitaire Peek-Optima Anterior Spinal SystemBiomet Spine2008854—
+2K212075ShurFit Lumbar Interbody SystemPrecision Spine, Inc.20211—
+2K181357PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc.201897—
+2K181030Rubicon Lumbar Interbody Fusion SystemRubicon Spine, LLC20180—
+2K170389TAURUS PEEK Cage SystemMedyssey USA, Inc.20170—
+2K152200SurgTech Interbody SystemSurgtech, Inc.20160—
+2K152355Twin Peaks Lumbar Interbody Fusion SystemSpineway20151—
+2K141665NuVasive CoRoent SystemNuvasive, Inc.2015588—
+2K143163AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK Spacer…Stryker Corporation2015636—
+2K142066Aero-LL Lumbar Cage SystemStryker Corporation20142—
+2K140474Juliet OLSpineart2014120—
+2K133557Juliet LL Lateral Lumbar CageSpineart2014147—
+2K133126K7 Lumbar SpacersK7, LLC20131—
+2K130641Logic Stand-Alone Intervertebral Body Fusion DeviceBinder Biomedical, Inc.20130—
+2K122639Synthes Syncage Evolution SpacerSynthes (USA) Products, LLC2013143—
+2K120869Anchor-L Lumbar CageStryker Spine2012638—
+2K121567Oracle Lumbar Intervertebral Body Fusion Cage SystemAccel Spine20125—
+2K121096Venus Lumbar Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd.201236—
+2K120203TM-400 DeviceZimmer Trabecular Metal Technology, Inc.201220—
+2K120345Honour Spacer SystemNexxt Spine, LLC2012212—
+2K113796Solitaire-C Cervical Spacer SystemEbi, LLC20121421
+2K120063Venus Lumbar Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd.201237—
+2K120557Solitarie Peek Anterior Spinal System-to BE Called Colitaire 35Biomet Spine & Bone Healing Technologies20121—
+2K113540Reliance Lumbar Ibf SystemReliance Medical Systems, LLC201212—
+2K111792Mobis, Moval, Semial, Tetrismodel Peek and Titanium, Kimba Model Standard and MiniSignus Medizintechnik GmbH2012470—
+2K110442Nanovis Intervertebral Body Fusion SystemNanovis, LLC201110—
+2K110783Venus Interbody Fixation System- Venus Plif/Tlif, Alif Peek CageL&K BIOMED Co., Ltd.201138—
+2K112014Zyston Straight Spacer SystemBiomet Spine2011174—
+2K103814Pezo Interbody Cages SystemUlrich GmbH & Co. KG20114—
+2K101051Avs a-Lat Peek Spacers, Models 48750XXX, 48751XXX, 48752XXX, 48753XXXStryker Spine2010641—
+2K100802Aesculap Implant Systems Sibd Spinal SystemAesculap Implant Systems, Inc.2010461—
+2K093808Incite Innovation Stand Alone Interbody Fusion DeviceIncite Innovation, LLC2010113—
+2K093629Solitaire and Solitaire Peek Anterior Spinal SystemBiomet Spine20101431
+2K091301Life Spine Stand-Alone Spacer SystemLife Spine2009473—
+2K083475Lucent MagnumSpinal Elements, Inc.2009834—
+2K082406Expandable Peek-Optima ImplantEbi, L.P.2009527—
+3K253559Ventana™ A Anterior Lumbar Interbody SystemSpinal Elements, Inc.20260—
+3K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+3K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+3K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+3K221172FOCUS Interbody SystemOc Medical Devices20220—
+3K214047EL CAPITAN Anterior Lumbar Interbody Fusion SystemAstura Medical20223—
+3K213441PathLoc Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20222—
+3K212389Advantage Lumbar System - ALIF, PLIF, DLIF, TLIFIntelivation, LLC20210—
+3K210214NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody SystemNu Vasive, Incorporated20213—
+3K201671A-Link ZAcuity Surgical Devices, LLC202125—
+3K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+3K202820Australis Anterior Lumbar Cage SystemPrism Surgical Designs Pty, Ltd.20200—
+3K192863MONDRIAN Lumbar Interbody Fusion Cage SystemCtl Medical Corporation20203—
+3K201585Monterey AL Interbody SystemStryker Corporation202044
+3K192492EL CAPITAN Anterior Lumber Interbody SystemAstura Medical, LLC202010—
+3K193541NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2020157—
+3K193412NEXXT MATRIXX SystemNexxt Spine, LLC20201—
+3K192115SABLE Expandable SpacerGlobus Medical, Inc.202037—
+3K191834Stand-Alone ALIF Titanium SystemLife Spine, Inc.20190—
+3K191822Nano FortiCore, FortiCoreNanovis, LLC20192—
+3K191537eCarbon IBDsBack 2 Basics Direct, LLC20193—
+3K191391HEDRON Lumbar SpacersGlobus Medical, Inc.201984—
+3K190708AccelFix Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20195—
+3K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC201993—
+3K183049Reliance Lumbar IBF SystemReliance Medical Systems, LLC20197—
+3K181118Reliance Lumbar IBF SystemReliance Medical Systems20190—
+3K181899Roccia® PlifSilony Medical GmbH20180—
+3K181963ostaPek Interbody Fusion CagesColigne AG20181—
+3K181860NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2018159—
+3K181591Fixated Asfora BULLET CAGE® (FABC)Medical Designs, LLC20180—
+3K181702Tranquil-L Interbody SystemNexus Spine, LLC20188—
+3K180215DYNA-LINK ELITE Stand-Alone Anterior Lumbar SystemLife Spine, Inc.20182—
+3K172480icotec Interbody Cage SystemIcotec AG20185—
+3K180687Reliance Lumber IBF SystemReliance Medical Systems20188—
+3K173182ProLift® Expandable SystemLife Spine, Inc.201737—
+3K172009Cascadia Interbody SystemK2m, Inc.2017433
+3K172341NuVasive® Modulus TLIF Interbody SystemNu Vasive, Incorporated2017163—
+3K170119Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc.201711
+3K171633NuVasive TLX Interbody SystemNu Vasive, Incorporated2017251—
+3K171140Matrixx SystemNexxt Spine, LLC2017145—
+3K170243LOSPA IS TLIF & DLIF CagesCorentec Co., Ltd.20170—
+3K163230NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2017276—
+3K163180Hubble IIOrbbo Surgical, LLC20160—
+3K161379ELSA SpacersGlobus Medical, Inc.2016155—
+3K153665Prow Fusion-LNlt Spine, Ltd.20160—
+3K161485Nanovis Intervertebral Body Fusion System and Forticore (R)Nanovis, LLC20165—
+3K161223TransContinental® M Spacers and InterContinental® Plate-SpacersGlobus Medical, Inc.2016117—
+3K153786Prow Fusion-VNlt Spine, Ltd.20166—
+3K160874Nanovis Intervertebral Body Fusion System and FortiCore®Nanovis, LLC20164—
+3K160463Reliance Lumbar IBF SystemReliance Medical Systems, LLC201611—
+3K153782NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated2016390—
+3K153627NuVasive® TLX Interbody SystemNu Vasive, Incorporated2016252—
+3K151665SUSTAIN Additional ImplantsGlobus Medical, Inc.2016119—
+3K151726AVS AL and AVS ALign PEEK Spacers, AVS PL and AVS UniLIF PEEK Spacers, AVS TL PEEK…Stryker Corporation20161391
+3K152793Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.201629—
+3K152620Spine Wave Gen II Expandable Interbody SystemSpine Wave, Inc.20162—
+3K151310Amendia Interbody Fusion DevicesAmendia, Inc.2016169—
+3K151773CONCORDE Bullet Lumbar Interbody SystemMedos International SARL2015201—
+3K152304Tritanium PL CageStryker20154481