510(k) Report

Devices descending from K041888

1,586 later devices reach Curved Peek Tetris Spinal Implant through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K173153Vertera Spine™ Coalesce™ Thoracolumbar Interbody Fusion SystemNu Vasive, Incorporated2017160—
+6K172392Lateral Spinal Truss System (LSTS) Interbody Fusion Device4Web, Inc.20171—
+6K172328SOVEREIGN™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201730—
+6K172341NuVasive® Modulus TLIF Interbody SystemNu Vasive, Incorporated2017163—
+6K172343Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D TechnologyRti Surgical, Inc.201710—
+6K172123NuVasive® Modulus XLIF Interbody SystemNu Vasive, Incorporated2017227—
+6K171633NuVasive TLX Interbody SystemNu Vasive, Incorporated2017251—
+6K170157INDEPENDENCE® SpacersGlobus Medical, Inc.2017109—
+6K172199ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT…Medtronic Sofamor Danek20176—
+6K163422Shanghai Sanyou PEEK Cage SystemShanghai Sanyou Medical Co, Ltd.20173—
+6K171351Posterior Spine Truss System (PSTS) Interbody Fusion Device4Web, Inc.20177—
+6K172489Reliance Cervical IBF SystemReliance Medical Systems, LLC201716—
+6K170851Anterior Spine Truss System (STS) Interbody Fusion Device4Web, Inc.20175—
+6K170919The TiBow Expandable Spacer SystemLife Spine, Inc.20171—
+6K171075Calix-C Cervical Interbody SpacerX-Spine Systems, Inc.201715—
+6K171749Velofix (tm) Interbody Fusion SystemU&I Corporation20175—
+6K171031CRESCENT™ Spinal SystemMedtronic Sofamor Danek2017144—
+6K171468FUSE Spinal SystemMedtronic Sofamor Danek20170—
+6K170961NuVasive CoRoent Small Interlock II SystemNu Vasive, Incorporated201718—
+6K170395Talos® Lumbar (HA) PEEK IBF DevicesMeditech Spine, LLC201710—
+6K163673Fortilink™-C with TETRAfuse™ 3D TechnologyRti Surgical, Inc.201711—
+6K162212Divergence-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc.201757—
+6K163670Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20173—
+6K170592NuVasive BASE Interfixated Titanium SystemNu Vasive, Incorporated2017186—
+6K163581Navigated ELEVATE Inserter, Navigated Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.2017103—
+6K162206Zavation IBFZavation, LLC201724—
+6K170512Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC20176—
+6K162918Atlas Spine Expandable Interbody SystemAtlas Spine, Inc.201729—
+6K162680SOVEREIGN® Spinal SystemMedtronic Sofamor Danek USA, Inc.201631—
+6K160222OIC Cervical PEEK SpacerThe Orthopaedic Implant Company20160—
+6K162431Luna 3D Interbody Fusion SystemBenvenue Medical, Inc.20163—
+6K160924Amendia Interbody Fusion DevicesAmendia, Inc.2016166—
+6K162944Irix-C Cervical Integrated Fusion SystemX-Spine Systems, Inc.20161—
+6K162358T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution SystemSynthes USA Products, LLC2016127—
+6K161379ELSA SpacersGlobus Medical, Inc.2016155—
+6K161442NuVasive® CoRoent® Small Interlock™ SystemNu Vasive, Incorporated201694—
+6K160066Pro-Link® Stand-Alone Cervical Spacer SystemLife Spine, Inc.20163—
+6K160597INDEPENDENCE MIS SpacersGlobus Medical, Inc.2016111—
+6K161230NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated2016381—
+6K161404Genesys Spine Apache® Lateral Lumbar Interbody Fusion SystemGenesys Spine201610—
+6K161223TransContinental® M Spacers and InterContinental® Plate-SpacersGlobus Medical, Inc.2016117—
+6K160631Keos Lumbar IBFDKeos20161—
+6K160906Rampart O Lumbar Interbody Fusion Device, Rampart T Lumbar Interbody Fusion Device…Spineology, Inc.201627—
+6K153786Prow Fusion-VNlt Spine, Ltd.20166—
+6K152622Alta ACDF SystemBiomet Spine20160—
+6K160874Nanovis Intervertebral Body Fusion System and FortiCore®Nanovis, LLC20164—
+6K160916CoRoent® Ti-C SystemNu Vasive, Incorporated2016139—
+6K153517AnyPlus® Cervical PEEK Cage SystemGS Medical Co., Ltd.201612—
+6K153436LATERAL Spine Truss System4Web, Inc.20165—
+6K153629ArcadiusXP C Spinal SystemAesculap Implant Systems, Inc.20167—
+6K153615NeoFuse HA Enhanced PLIF/TLIFHt Medical, LLC201650—
+6K153783SpaceVision® PLIF, SpaceVision® OLIF, SpaceVision® TLIFSpinevision S.A.201613—
+6K153495Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T…Ldr Spine USA20161891
+6K153627NuVasive® TLX Interbody SystemNu Vasive, Incorporated2016252—
+6K153250Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies201632—
+6K160418PERIMETER Interbody Fusion DeviceMedtronic Sofamor Danek USA, Inc.20165—
+6K153438PERIMETER C (Titanium) Spinal SystemMedtronic Sofamor Danek USA, Inc.20160—
+6K151310Amendia Interbody Fusion DevicesAmendia, Inc.2016169—
+6K152943NuVasive Foundation-LL SystemNu Vasive, Incorporated2015187—
+6K152277PIVOX (tm) Oblique Lateral Spinal SystemMedtronic Sofamor Danek USA, Inc.2015190—
+6K151785Px HA PEEK IBF SystemInnovasis, Inc.201557—
+6K151472NuVasive CoRoent Lumbar SystemNu Vasive, Incorporated2015479—
+6K151322Amendia Interbody Fusion DevicesAmendia, Inc.20152261
+6K151756Sterispine LC CageSafe Orthopaedics20150—
+6K151128CAPSTONE Spinal System, CLYDESDALE Spinal SystemMedtronic Sofamor Danek USA, Inc.2015255—
+6K151374NuVasive MLX-Medial Lateral Expandable Lumbar Interbody System, NuVasive AP Expandable…Nu Vasive, Incorporated2015235—
+6K151184InFill Interbody Fusion DevicesPinnacle Spine Group, LLC20153—
+6K150994NuVasive CoRoent Thoracolumbar ImplantsNu Vasive, Incorporated2015402—
+6K150231Navigated Disc Prep Instruments and CAPSTONE TrialsMedtronic Sofamor Danek USA, Inc.2015242—
+6K142645Avenue T TLIF CageLdr Spine USA, Inc.2015191—
+6K142269Reliance Cervical IBF SystemReliance Medical Systems, LLC201523—
+6K150954Elite L Expandable Lumbar Fusion SystemInnova Spinal Technologies, LLC20156—
+6K142392Zavation Posterior LEIFZavation, LLC20150—
+6K143595NuVasive (R) CCX-L Interbody SystemNu Vasive, Incorporated2015253—
+6K143360LnK Cervical Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20159—
+6K150206InFill Interbody Fusion DevicesPinnacle Spine Group, LLC20152—
+6K141187Impix Alif S/aMedicrea International SA201501
+6K142271Zavation Z-Link LumbarZavation, LLC20149—
+6K142299CoRoent Small Interlock SystemNu Vasive, Incorporated201499—
+6K142101Abacus (TM) Spacer SystemSpine Wave, Inc.20140—
+6K142095Renovis S134 Anterior Lumbar Interbody Fusion (Alif) SystemRenovis Surgical Technologies, Inc.2014254—
+6K142277Juliet POSpineart2014119—
+6K140280ForticoreNanovis, LLC20149—
+6K141005Z-Link CervicalZavation, LLC20144—
+6K133947Irix-a Lumbar Integrated Fusion SystemX-Spine Systems, Inc.20142—
+6K140479Coroent XL-F SystemNu Vasive, Incorporated2014465—
+6K140709Skyhawk Interbody Fusion SystemOrthofix, Inc.20147—
+6K140303Alamo TAlliance Partners, LLC20140—
+6K140474Juliet OLSpineart2014120—
+6K134038Camber Spine Diagon Oblique CageCamber Spine201428—
+6K133893Sterispine LC CageSafe Orthopaedics20141—
+6K133557Juliet LL Lateral Lumbar CageSpineart2014147—
+6K133192Mectalif TipeekMedacta International201416—
+6K123758Tasmin RSignus Medizintechnik GmbH20141—
+6K133216Crescent Spinal SystemMedtronic Sofamor Danek, Inc.201392—
+6K132700Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek, Inc.2013170—
+6K131429Reliance Cervical Ibf SystemReliance Medical Systems, LLC201324—
+6K130641Logic Stand-Alone Intervertebral Body Fusion DeviceBinder Biomedical, Inc.20130—
+6K123027Capstone (R) Spinal SystemMedtronic Sofamor Danek, Inc.2013709—
+6K122957Tezo Titanium Cage FamilyUlrich GmbH & Co. KG20130—