510(k) Report

Devices descending from K073470

1,102 later devices reach Avs PL Peek Spacers, Models 48351XXX and 48353XXX through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K152200SurgTech Interbody SystemSurgtech, Inc.20160—
+1K151408LOSPA IS Spinal SystemCorentec Co., Ltd.20151—
+1K132738Cogent Med-LifCogent Spine, LLC201413—
+1K133126K7 Lumbar SpacersK7, LLC20131—
+1K120869Anchor-L Lumbar CageStryker Spine2012638—
+1K120345Honour Spacer SystemNexxt Spine, LLC2012212—
+1K111792Mobis, Moval, Semial, Tetrismodel Peek and Titanium, Kimba Model Standard and MiniSignus Medizintechnik GmbH2012470—
+1K112014Zyston Straight Spacer SystemBiomet Spine2011174—
+1K103814Pezo Interbody Cages SystemUlrich GmbH & Co. KG20114—
+1K100865Ava Navigator Peek Spacers, Model 48392XXX, 48393XXXStryker Spine2010637—
+1K090816Stryker Spine Avs PL Peek SpacersStryker Corp.2009756—
+1K090166Avs Anterior Large Peek SpacersStryker Corp.2009683—
+1K083661Avs TL Peek SpacersStryker Corp.2009757—
+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—
+1K080758Avs PL Peek Spacers, Models 48351 and 48353Stryker Corp.20081,091—
+2K212075ShurFit Lumbar Interbody SystemPrecision Spine, Inc.20211—
+2K201585Monterey AL Interbody SystemStryker Corporation202044
+2K193412NEXXT MATRIXX SystemNexxt Spine, LLC20201—
+2K191537eCarbon IBDsBack 2 Basics Direct, LLC20193—
+2K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC201993—
+2K181357PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc.201897—
+2K181030Rubicon Lumbar Interbody Fusion SystemRubicon Spine, LLC20180—
+2K172480icotec Interbody Cage SystemIcotec AG20185—
+2K170389TAURUS PEEK Cage SystemMedyssey USA, Inc.20170—
+2K170119Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc.201711
+2K171140Matrixx SystemNexxt Spine, LLC2017145—
+2K170243LOSPA IS TLIF & DLIF CagesCorentec Co., Ltd.20170—
+2K151406Cogent Lateral Interbody SystemCogent Spine, LLC201611—
+2K152620Spine Wave Gen II Expandable Interbody SystemSpine Wave, Inc.20162—
+2K152355Twin Peaks Lumbar Interbody Fusion SystemSpineway20151—
+2K143572Intersomatic Cervical Device - DICOM PEEK, Intersomatic Intervertebral Space Maintenance…Osteomed Implantes, Ltda20150—
+2K141665NuVasive CoRoent SystemNuvasive, Inc.2015588—
+2K143163AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK Spacer…Stryker Corporation2015636—
+2K133827A-Link ZOsteo Vasive, LLC2014262
+2K142066Aero-LL Lumbar Cage SystemStryker Corporation20142—
+2K142193Cogent Med-Lif XLCogent Spine, LLC201412—
+2K141443Infront Lumbar Interbody Fusion SystemInfront Medical, LLC20142—
+2K141376Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx, Struxxure Anterior…Nexxt Spine, LLC2014106—
+2K140474Juliet OLSpineart2014120—
+2K133529Camber Spine Coveris Cervical CageCamber Spine201410—
+2K133557Juliet LL Lateral Lumbar CageSpineart2014147—
+2K132894Optio-C Anterior Cervical SystemZimmer Spine, Inc.201424—
+2K123758Tasmin RSignus Medizintechnik GmbH20141—
+2K130641Logic Stand-Alone Intervertebral Body Fusion DeviceBinder Biomedical, Inc.20130—
+2K131077Life Spine Plateau Spacer SystemLife Spine201310—
+2K131372Mobis IISignus Medizintechnik GmbH2013462—
+2K122957Tezo Titanium Cage FamilyUlrich GmbH & Co. KG20130—
+2K122639Synthes Syncage Evolution SpacerSynthes (USA) Products, LLC2013143—
+2K122989Biomet Lateral Spacer SystemBiomet Spine (Aka Ebi, LLC)2012171—
+2K121567Oracle Lumbar Intervertebral Body Fusion Cage SystemAccel Spine20125—
+2K122444Cervical CageEisertech, LLC201222—
+2K122317Tetris IISignus Medizintechnik GmbH20122—
+2K121096Venus Lumbar Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd.201236—
+2K120203TM-400 DeviceZimmer Trabecular Metal Technology, Inc.201220—
+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—
+2K111820Synster Cervical Cage, Alif Cage, Plif Cage, Ptlif Cage, Tlif CageBm Korea Co., Ltd.201220—
+2K113540Reliance Lumbar Ibf SystemReliance Medical Systems, LLC201212—
+2K110442Nanovis Intervertebral Body Fusion SystemNanovis, LLC201110—
+2K110783Venus Interbody Fixation System- Venus Plif/Tlif, Alif Peek CageL&K BIOMED Co., Ltd.201138—
+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—
+2K093864Avs Align Peek Spacers Model 48328XXX, 48326XXXStryker Corp.2010637—
+2K093629Solitaire and Solitaire Peek Anterior Spinal SystemBiomet Spine20101431
+2K091301Life Spine Stand-Alone Spacer SystemLife Spine2009473—
+2K092017Pivotec Lumbar Interbody Fusion Device (Lifd)Captiva Spine, Inc.200924—
+2K083475Lucent MagnumSpinal Elements, Inc.2009834—
+2K082406Expandable Peek-Optima ImplantEbi, L.P.2009527—
+3K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+3K253559Ventana™ A Anterior Lumbar Interbody SystemSpinal Elements, Inc.20260—
+3K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+3K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+3K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc.20251—
+3K241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc.20241—
+3K241438Signus Tetris™ St; Signus Tetris™ R StSignus Medizintechnik GmbH20240—
+3K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+3K232792icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec…Icotec AG20240—
+3K233375Tranquil-L Interbody SystemNexus Spine, LLC20240—
+3K230478Acro Composites Interbody SystemAcro Composites, LLC20230—
+3K232481RIGEL™ 3DR Anterior Cervical Corpectomy SystemMiRus, LLC20230—
+3K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+3K222015Integral Titanium Cervical InterbodyNvision Biomedical Technologies, Inc.20231—
+3K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+3K221162UniVy OsteoVy Cervical IBF SystemVy Spine, LLC20222—
+3K221172FOCUS Interbody SystemOc Medical Devices20220—
+3K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+3K214047EL CAPITAN Anterior Lumbar Interbody Fusion SystemAstura Medical20223—
+3K202266Reliance Cervical IBF SystemReliance Medical Systems, LLC20223—
+3K213441PathLoc Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20222—
+3K212389Advantage Lumbar System - ALIF, PLIF, DLIF, TLIFIntelivation, LLC20210—
+3K210470C-CURVE Interbody Fusion DeviceMedicrea International SA20210—
+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—
+3K203520Blustone Synergy Interbody Fusion SystemBlustone Synergy, LLC20210—