510(k) Report

Devices descending from K093242

921 later devices reach Patriot Transcontinental Llif Spacer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K200338ProLift Lateral FixatedLife Spine, Inc.20205—
+3K192006SIRION Lateral Lumbar Interbody SystemAstura Medical, LLC202014—
+3K193418SeaSpine Skipjack SystemSeaSpine Orthopedics Corporation20204—
+3K193203MOJAVE Expandable Interbody SystemK2m, Inc.202015—
+3K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+3K192026Peridot Intervertebral body fusion SystemGbs Commonwealth Co., Ltd.20196—
+3K192248Cortina™ [MAX] Lumbar Cage SystemNeurostructures, Inc.20190—
+3K190721LongBow TiLife Spine, Inc.20190—
+3K191477AEON-C Stand Alone SystemHuvexel Co., Ltd.201910—
+3K192760NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2019163—
+3K191243HEDRON Cervical SpacersGlobus Medical, Inc.201936—
+3K191354Ti3Z Cervical Interbody SystemZavation Medical Products, LLC201913—
+3K191339Zavation eZspand Interbody SystemZavation Medical Products, LLC20195—
+3K190885Elevation Spine Saber-C SystemElevation Spine201925—
+3K183249Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved…Stryker Spine20196—
+3K190488ProLift Expandable SystemLife Spine, Inc.201916—
+3K183243Velofix TLIF CageU&I Corporation20190—
+3K190889Republic Spine Restore Cervical Interbody Fusion SystemRepublic Spine, LLC20190—
+3K191005ProLift® Expandable SystemLife Spine, Inc.201918—
+3K173518Spectrum Spine Expandable Cages (SSEC)Spectrum Spine, LLC20196—
+3K183083Shoreline Cervical Interbody RT SystemSeaSpine Orthopedics Corporation201960—
+3K182284Tyber Medical PT Interbody SpacerTyber Medical, LLC20195—
+3K182114FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20196—
+3K181829Velofix TLIF CageU&I Corporation20181—
+3K181531SpineEX Sagittae Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20183—
+3K181397DualXInnovasive, Inc.201815—
+3K181591Fixated Asfora BULLET CAGE® (FABC)Medical Designs, LLC20180—
+3K180777K2M Expandable Interbody SystemK2m, Inc.20180—
+3K180675Atlas Spine Expandable Cervical Interbody SystemAtlas Spine, Inc.20182—
+3K172480icotec Interbody Cage SystemIcotec AG20185—
+3K173832InTice™-C Porous Ti Cervical Interbody SystemX-Spine Systems, Inc.201801
+3K173347STALIF C FLX, STALIF M FLX, STALIF L FLX and STALIF Lateral-Oblique FLX, ACTILIF C FLX…Centinel Spine, Inc.201812—
+3K173082Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20185—
+3K172105The Plateau-LO Spacer SystemLife Spine, Inc.20181—
+3K172696FORZA® XP Expandable Spacer SystemOrthofix, Inc.201825—
+3K172349InFill® Interbody Fusion DevicePinnacle Spine Group, LLC20171—
+3K171914Cortina™ Lumbar Cage SystemNeurostructures, Inc.20172—
+3K172123NuVasive® Modulus XLIF Interbody SystemNu Vasive, Incorporated2017227—
+3K170119Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc.201711
+3K172199ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT…Medtronic Sofamor Danek20176—
+3K170919The TiBow Expandable Spacer SystemLife Spine, Inc.20171—
+3K171425Concorde LiftMedos International SARL201782
+3K170503EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular…Eit Emerging Implant Technologies GmbH20171992
+3K171097MOJAVE Expandable Interbody SystemK2m, Inc.201717—
+3K163581Navigated ELEVATE Inserter, Navigated Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.2017103—
+3K170243LOSPA IS TLIF & DLIF CagesCorentec Co., Ltd.20170—
+3K162693VertebraLINK Fusion PlatformFacetlink Dba Linkspine20170—
+3K162760Spine Wave Anterior Cervical Spine SystemSpine Wave, Inc.20171—
+3K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation201679—
+3K161993Leva® Anterior Interbody SystemSpine Wave, Inc.20160—
+3K153665Prow Fusion-LNlt Spine, Ltd.20160—
+3K160597INDEPENDENCE MIS SpacersGlobus Medical, Inc.2016111—
+3K153786Prow Fusion-VNlt Spine, Ltd.20166—
+3K152011Lucent Intervertebral Body Fusion DeviceSpinal Elements, Inc.2016106—
+3K160051NuVasive® Interfixated Interbody SystemNu Vasive, Incorporated2016396—
+3K153495Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T…Ldr Spine USA20161891
+3K153782NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated2016390—
+3K153627NuVasive® TLX Interbody SystemNu Vasive, Incorporated2016252—
+3K153400ProLift Expandable SystemLife Spine, Inc.201672—
+3K152539SpineView X-Pac Expandable Lumbar Cage SystemSpine View, Inc.20166—
+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—
+3K151481Sahara Stabilization SystemK2m, Inc.20155—
+3K151773CONCORDE Bullet Lumbar Interbody SystemMedos International SARL2015201—
+3K152304Tritanium PL CageStryker20154481
+3K150788Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral Body Fusion…Meditech Spine, LLC2015202—
+3K150673SYNFIX Evolution Secured Spacer SystemSynthes (USA) Products, LLC2015137—
+3K151483Biomet Spine Fusion SystemBiomet Spine, LLC20154—
+3K151184InFill Interbody Fusion DevicesPinnacle Spine Group, LLC20153—
+3K142645Avenue T TLIF CageLdr Spine USA, Inc.2015191—
+3K143595NuVasive (R) CCX-L Interbody SystemNu Vasive, Incorporated2015253—
+3K150206InFill Interbody Fusion DevicesPinnacle Spine Group, LLC20152—
+3K141665NuVasive CoRoent SystemNuvasive, Inc.2015588—
+3K143616AccuLIF TL and PL CageStryker Corporation20154694
+3K143228Ancora LLC Interbody Fusion DeviceFrontier Medical Devices, Inc.20150—
+3K142023Luna Interbody SystemBenvenue Medical, Inc.20145—
+3K142066Aero-LL Lumbar Cage SystemStryker Corporation20142—
+3K133813Flxfit Intervertebral Body Fusion DeviceExpanding Orthopedics, Inc.2014137—
+3K123607Octane Elevate Spinal Implant SystemExactech, Inc.20141—
+3K133583Opticage Interbody Fusion Device, Model Series 9070Interventional Spine, Inc.20140—
+3K132559Monument SpacersGlobus Medical, Inc.2013166—
+3K133207Staxx (R) SystemSpine Wave, Inc.20131—
+3K131071Staxx Ibl SystemSpine Wave, Inc.20138—
+3K130194Acculif XL CageCoalign Innovations, Inc.20131—
+3K123281Acculif TL-Peek CageCoalign Innovations, Inc.2013146—
+3K123752Acculif TL and PL CageCoalign Innovations, Inc.2013676—
+3K121683Acculif TL CageCoalign Innovations, Inc.2012682—
+4K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+4K261430TruLift Expandable SystemLife Spine, Inc.20260—
+4K2530413d Cage CervicalFims Co., Ltd.20260—
+4K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+4K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+4K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+4K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+4K253151Fule Interbody Fusion Cage SystemBeijing Fule Science & Technology Development Co., Ltd.20260—
+4K260840BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20261—
+4K261067BEE PLIF CageNGMedical GmbH20260—
+4K260660SABER-C SystemElevation Spine20261—
+4K253748Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer SystemLife Spine, Inc.20260—
+4K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—