510(k) Report

Devices descending from K082014

837 later devices reach Stryker Spine Avs PL Peek Spacers through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K152200SurgTech Interbody SystemSurgtech, Inc.20160—
+1K152355Twin Peaks Lumbar Interbody Fusion SystemSpineway20151—
+1K142066Aero-LL Lumbar Cage SystemStryker Corporation20142—
+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—
+1K101051Avs a-Lat Peek Spacers, Models 48750XXX, 48751XXX, 48752XXX, 48753XXXStryker Spine2010641—
+1K100865Ava Navigator Peek Spacers, Model 48392XXX, 48393XXXStryker Spine2010637—
+1K090816Stryker Spine Avs PL Peek SpacersStryker Corp.2009756—
+2K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+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—
+2K170119Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc.201711
+2K171140Matrixx SystemNexxt Spine, LLC2017145—
+2K170243LOSPA IS TLIF & DLIF CagesCorentec Co., Ltd.20170—
+2K163180Hubble IIOrbbo Surgical, LLC20160—
+2K152620Spine Wave Gen II Expandable Interbody SystemSpine Wave, Inc.20162—
+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
+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—
+2K131077Life Spine Plateau Spacer SystemLife Spine201310—
+2K131372Mobis IISignus Medizintechnik GmbH2013462—
+2K122957Tezo Titanium Cage FamilyUlrich GmbH & Co. KG20130—
+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—
+2K120063Venus Lumbar Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd.201237—
+2K113540Reliance Lumbar Ibf SystemReliance Medical Systems, LLC201212—
+2K110783Venus Interbody Fixation System- Venus Plif/Tlif, Alif Peek CageL&K BIOMED Co., Ltd.201138—
+3K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+3K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+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—
+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—
+3K221162UniVy OsteoVy Cervical IBF SystemVy Spine, LLC20222—
+3K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+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—
+3K203520Blustone Synergy Interbody Fusion SystemBlustone Synergy, LLC20210—
+3K210359Hexanium TLIFSpinevision, S.A.S.20211—
+3K203683CarboClear Lumbar Cage SystemCarbofix Orthpedics, Ltd.20211—
+3K193000Hexanium® ACIFSpinevision, S.A.S.202014—
+3K192863MONDRIAN Lumbar Interbody Fusion Cage SystemCtl Medical Corporation20203—
+3K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC202025—
+3K200969NEXXT MATRIXX SystemNexxt Spine, LLC20200—
+3K192492EL CAPITAN Anterior Lumber Interbody SystemAstura Medical, LLC202010—
+3K192145Galileo Vertebral Body Replacement DeviceBright Spine20201—
+3K193541NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2020157—
+3K200543NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) SystemNexxt Spine, LLC202072—
+3K192897icotec Cervical CageIcotec AG20201—
+3K193378CarboClear Lumbar Cage SystemCarboFix Orthopedics, Ltd.20202—
+3K193370Nexxt Matrixx SystemNexxt Spine, LLC20202—
+3K192115SABLE Expandable SpacerGlobus Medical, Inc.202037—
+3K192687TrellOss™-L MPFNexxt Spine, LLC20201—
+3K191391HEDRON Lumbar SpacersGlobus Medical, Inc.201984—
+3K190708AccelFix Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20195—
+3K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer…Choice Spine, LLC20194—
+3K191408Nexxt Matrixx SystemNexxt Spine, LLC20190—
+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—
+3K181435ATEC Cervical Spacer SystemAlphatec Spine, Inc.2018100—
+3K181115CxHA PEEK Cervical IBF SystemInnovasis, Inc.20188—
+3K180687Reliance Lumber IBF SystemReliance Medical Systems20188—
+3K173347STALIF C FLX, STALIF M FLX, STALIF L FLX and STALIF Lateral-Oblique FLX, ACTILIF C FLX…Centinel Spine, Inc.201812—
+3K173077Cavetto-SA Cervical Cage SystemNeurostructures, Inc.201821—
+3K173182ProLift® Expandable SystemLife Spine, Inc.201737—
+3K172009Cascadia Interbody SystemK2m, Inc.2017433
+3K172446SPIRA-C Open Matrix Cervical InterbodyCamber Spine Technologies20176—