510(k) Report

Devices descending from K020048

1,559 later devices reach Modification to Geo Structure through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K200816SpineEX Sagittae Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20201—
+6K192145Galileo Vertebral Body Replacement DeviceBright Spine20201—
+6K200338ProLift Lateral FixatedLife Spine, Inc.20205—
+6K200052CONSTRUX Mini PTC Spacer System, FORZA PTC Spacer System, PILLAR SA PTC Spacer SystemOrthofix, Inc.202013—
+6K191788CAPSTONE Spinal System, CLYDESDALE PTC Spinal System, CRESCENT Spinal System, CRESCENT…Medtronic Sofamor Danek USA, Inc.20200—
+6K193506NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR SystemNu Vasive, Incorporated20201—
+6K193412NEXXT MATRIXX SystemNexxt Spine, LLC20201—
+6K193521Steerable Plateau TiLife Spine, Inc.20201—
+6K192993Scarlet AL-TSpineart20201—
+6K193370Nexxt Matrixx SystemNexxt Spine, LLC20202—
+6K192115SABLE Expandable SpacerGlobus Medical, Inc.202037—
+6K192687TrellOss™-L MPFNexxt Spine, LLC20201—
+6K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine20207—
+6K192026Peridot Intervertebral body fusion SystemGbs Commonwealth Co., Ltd.20196—
+6K1803473d CageFims Co., Ltd.20190—
+6K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer…Choice Spine, LLC20194—
+6K191311ATEC Lateral Interbody SystemAlphatec Spine, Inc.201978—
+6K191408Nexxt Matrixx SystemNexxt Spine, LLC20190—
+6K190684LxHA PEEK Lateral IBF SystemInnovasis, Inc.20190—
+6K191005ProLift® Expandable SystemLife Spine, Inc.201918—
+6K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC201993—
+6K190877Juliet® Ti LL Lumbar Interbody DeviceSpineart201911
+6K183560Luna 3D GEN2 Interbody Fusion SystemBenvenue Medical, Inc.20192—
+6K190165Capstone Control™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20196—
+6K183092Kuros TLIF CageKuros Biosciences B.V20190—
+6K183397ChoiceSpine Stealth Cervical Spacer SystemChoicespine, LP201916—
+6K190193SpineEX Sagittae® Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20192—
+6K182406Altus Spine Interbody Fusion SystemAltus Partners, LLC20191—
+6K183588Choice Spine Hawkeye Vertebral Body Replacement (VBR) SystemChoicespine20195—
+6K183447EIT Cellular Titanium Lumbar Cage - T/PLIFEit Emerging Implant Technologies GmbH2019131—
+6K180228II-Type Intervertebral SpacerPaonan Biotech Co., Ltd.20191—
+6K182007Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies20180—
+6K182746ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc.2018110—
+6K181921Solidity Vertebral Body ReplacementUlrich Medical USA20182—
+6K181963ostaPek Interbody Fusion CagesColigne AG20181—
+6K182195Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20183—
+6K181644EIT Cellular Titanium® Lumbar Cage LLIFEit Emerging Implant Technologies GmbH2018141—
+6K181397DualXInnovasive, Inc.201815—
+6K181591Fixated Asfora BULLET CAGE® (FABC)Medical Designs, LLC20180—
+6K181380LnK Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.201810—
+6K181435ATEC Cervical Spacer SystemAlphatec Spine, Inc.2018100—
+6K181030Rubicon Lumbar Interbody Fusion SystemRubicon Spine, LLC20180—
+6K180675Atlas Spine Expandable Cervical Interbody SystemAtlas Spine, Inc.20182—
+6K180519HARRIER-SA™ Lumbar Interbody SystemChoicespine, LP20180—
+6K180078Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF SystemInnovasis, Inc.2018551
+6K172696FORZA® XP Expandable Spacer SystemOrthofix, Inc.201825—
+6K171848FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO…Globus Medical, Inc.201755—
+6K172888EIT Cellular Titanium® Cervical Cages, EIT Cellular Titanium® PLIF Cages, EIT Cellular…Eit Emerging Implant Technologies GmbH2017159—
+6K172349InFill® Interbody Fusion DevicePinnacle Spine Group, LLC20171—
+6K170553Altus Spine Interbody Fusion SystemAltus Partners, LLC20170—
+6K170235Lucent®Spinal Elements, Inc.2017107—
+6K172253Altus Spine Cervical Interbody Fusion SystemAltus Partners, LLC20170—
+6K170119Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc.201711
+6K171107CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal SystemMedtronic Sofamor Danek USA, Inc.20178—
+6K171329Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC20172—
+6K170643Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) SystemRti Surgical, Inc. Dba Rti Biologics201711—
+6K170512Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC20176—
+6K161173Avenue® T TLIF CageLdr Spine USA, Inc.20163—
+6K161404Genesys Spine Apache® Lateral Lumbar Interbody Fusion SystemGenesys Spine201610—
+6K153105MLX™ - Medial Lateral Expandable Lumbar Interbody SystemNu Vasive, Incorporated2016234—
+6K153123Genesys Spine Apache Interbody Fusion SystemGenesys Spine201612—
+6K153356Spine Innovation Interbody SystemSpine Innovation, LLC20161—
+6K151900VariLift-L Interbody Fusion DeviceWenzel Spine, Inc.20158—
+6K151056Aesculap T-Space PEEK and XP Spinal SystemAesculap Implant Systems, LLC20150—
+6K151654Prow FusionNlt Spine, Ltd.20151—
+6K150321EVOS Lumbar Interbody SystemCutting Edge Spine, LLC201592—
+6K150500Px PEEK IBF SystemInnovasis, Inc.201558—
+6K142559ELEVATE Spinal SystemMedtronic Sofamor Danek USA, Inc.2015130—
+6K150521Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) SystemRti Surgical, Inc. Dba Rti Biologics201512—
+6K141665NuVasive CoRoent SystemNuvasive, Inc.2015588—
+6K143214SCARLET® AC-T Secured Anterior Cervical CageSpineart20153—
+6K142023Luna Interbody SystemBenvenue Medical, Inc.20145—
+6K133827A-Link ZOsteo Vasive, LLC2014262
+6K140577Innesis Peek TL CageBk Meditech, Co., Ltd.20142—
+6K141314Scarlet AC-T Secured Anterior Cervical Cage and Associated InstrumentationSpineart201438—
+6K140563Lateral VBR SystemNu Vasive, Incorporated20140—
+6K140770MLX - Medial Lateral Expandable Lumbar Interbody SystemNu Vasive, Incorporated2014269—
+6K133053Milestone Spinal SystemWeigao Orthopaedic Device Co., Ltd.20142—
+6K140162AP Expandable Xlif SystemNuvasive, Inc.2014236—
+6K141376Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx, Struxxure Anterior…Nexxt Spine, LLC2014106—
+6K133494Chesapeake Spinal SystemK2m, Inc.2014330—
+6K123607Octane Elevate Spinal Implant SystemExactech, Inc.20141—
+6K132483Innesis Peek Cervical CageBk Meditech, Co., Ltd.20140—
+6K133455Crossfuse II Coronal Taper, Crossfuse II HyperlordoticPioneer Surgical Technology, Inc.20145961
+6K133529Camber Spine Coveris Cervical CageCamber Spine201410—
+6K133205Capstone PTC Spinal System, Clydesdale PTC Spinal SystemMedtronic Sofamor Danek USA, Inc.2014124—
+6K133623C-PLUSPioneer Surgical Technology, Inc.2014598—
+6K133557Juliet LL Lateral Lumbar CageSpineart2014147—
+6K132894Optio-C Anterior Cervical SystemZimmer Spine, Inc.201424—
+6K133645Perimeter C Spinal System, Capstone Spinal System, Capstone L Spinal System, Perimeter…Medtronic Sofamor Danek USA, Inc.20146—
+6K133650Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.2013344—
+6K132897Clydesdale Spinal SystemMedtronic Sofamor Danek, Inc.2013279—
+6K133126K7 Lumbar SpacersK7, LLC20131—
+6K133207Staxx (R) SystemSpine Wave, Inc.20131—
+6K130274Biolign Acif Systems, Biolign Stacc Acif System, Biolign Tlif SystemElite Surgical Supplies (Pty), Ltd.20139—
+6K131350Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc.2013214
+6K131178Idys Lif CagesClariance201311—
+6K131981Cezanne II Interbody Fusion SystemAccel Spine201354
+6K131122S128 Anterior Lumbar Interbody Fusion (Alif) SystemRenovis Surgical Technologies, LLC2013269—
+6K131296Varilift-L Interbody Fusion DeviceWenzel Spine, Inc.20130—