510(k) Report

Devices descending from K042268

1,620 later devices reach Ebi Cas Spine Spacer System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K173892NuVasive® XLX Interbody SystemNu Vasive, Incorporated2018115—
+5K180071STYLO Interbody Fusion DeviceLegend Spine Technologies20180—
+5K180078Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF SystemInnovasis, Inc.2018551
+5K173535Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TAS Hyperlordotic Interbody…Titan Spine, LLC20181052
+5K172941CASCADIA Interbody SystemK2m201852—
+5K172105The Plateau-LO Spacer SystemLife Spine, Inc.20181—
+5K172816TiGer Shark™ SystemChoicespine, LP201859—
+5K173508Everest Spinal SystemK2m20189—
+5K173159Cervical Spinal Truss System (CSTS) Interbody Fusion Device4Web, Inc.201812—
+5K173702Juliet Ti LLSpineart20182—
+5K173102Reliance Cervical IBF SystemReliance Medical Systems, LLC201715—
+5K172185Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20177—
+5K171848FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO…Globus Medical, Inc.201755—
+5K173115COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and…Globus Medical, Inc.201783—
+5K172465Idys™ TLIF 3DTi CagesClariance, Sas20176—
+5K172888EIT Cellular Titanium® Cervical Cages, EIT Cellular Titanium® PLIF Cages, EIT Cellular…Eit Emerging Implant Technologies GmbH2017159—
+5K170389TAURUS PEEK Cage SystemMedyssey USA, Inc.20170—
+5K170553Altus Spine Interbody Fusion SystemAltus Partners, LLC20170—
+5K172019Brisbane ALIF Device, Gladstone ALIF DeviceSignature Orthopaedics Pty, Ltd.20170—
+5K172253Altus Spine Cervical Interbody Fusion SystemAltus Partners, LLC20170—
+5K163595IMPIX 3D Print CagesMedicrea International SA2017282
+5K162315FORTIFY Corpectomy SpacersGlobus Medical, Inc.201755—
+5K172083Idys™ ALIF SystemClariance, Sas20177—
+5K172446SPIRA-C Open Matrix Cervical InterbodyCamber Spine Technologies20176—
+5K172328SOVEREIGN™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201730—
+5K172437CONSTRUX® Mini PTC Spacer System, FORZA® PTC Spacer System, PILLAR® SA PTC Spacer SystemOrthofix, Inc.2017143
+5K171489Acapella Cervical Spacer SystemChoicespine, LP201739—
+5K172123NuVasive® Modulus XLIF Interbody SystemNu Vasive, Incorporated2017227—
+5K171689ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2017109—
+5K172065Scarlet AC-TSpineart20172—
+5K171107CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal SystemMedtronic Sofamor Danek USA, Inc.20178—
+5K172587Mecta-C with titanium markers and Mecta-C TiPEEK with titanium markersMedacta International S.A.20170—
+5K172064Ti-Diagon Oblique TLIFCamber Spine Technologies201727—
+5K171686Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) SystemChoicespine2017116—
+5K172489Reliance Cervical IBF SystemReliance Medical Systems, LLC201716—
+5K171329Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC20172—
+5K171657ShurFit 2C Lumbar Interbody Fusion SystemPrecision Spine, Inc.20174—
+5K170888Renovis S141 Lumbar Interbody Fusion SystemRenovis Surgical Technologies20175—
+5K170550Coveris Cervical Cage SystemCamber Spine Technologies20171—
+5K170676HD Lumbar Interbody SystemHd Lifesciences, LLC2017122—
+5K170318NeoFuse Ti3D PLIF/TLIF/Cervical InterbodyHt Medical, LLC201749—
+5K171046SeaSpine Cambria SystemSeaSpine Orthopedics Corporation201762—
+5K170399Endoskeleton TO Interbody Fusion Device (IBD)Titan Spine, LLC2017105—
+5K170830Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20175—
+5K170569SeaSpine Shoreline ACS - Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation201782—
+5K171468FUSE Spinal SystemMedtronic Sofamor Danek20170—
+5K171097MOJAVE Expandable Interbody SystemK2m, Inc.201717—
+5K162496Foundation 3D InterbodyCorelink, LLC201782—
+5K170953Tomcat Cervical Spinal SystemChoicespine, LP2017103—
+5K170055CAPRI Corpectomy Cage SystemK2m201711—
+5K163491NuVasive CoRoent Small Interbody SystemNu Vasive, Incorporated2017289—
+5K152022SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION®…Globus Medical, Inc.2017149—
+5K1624024CIS® Marlin ACIF Cage SystemSolco Biomedical Co., Ltd.20171—
+5K162760Spine Wave Anterior Cervical Spine SystemSpine Wave, Inc.20171—
+5K162587Roccia® AcifSilony Medical GmbH20171—
+5K160976Altus Spine Interbody Fusion SystemAltus Partners, LLC20178—
+5K162531Sterispine CCSafe Orthopaedics20160—
+5K162003IMSE Cervical CageThe Institute of Musculoskeletal Science & Education20160—
+5K162327COUGAR® LS Lateral Cage System and COUGAR® SystemMedos International SARL2016111—
+5K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation201679—
+5K161993Leva® Anterior Interbody SystemSpine Wave, Inc.20160—
+5K160959Xsert Lumbar Expandable Interbody SystemX-Spine Systems, Inc.201612—
+5K160924Amendia Interbody Fusion DevicesAmendia, Inc.2016166—
+5K162138NuVasive CoRoent Small Ti-C SystemNu Vasive, Incorporated2016135—
+5K161642CAVUX™ Cervical CageProvidence Medical Technology, Inc.20160—
+5K161442NuVasive® CoRoent® Small Interlock™ SystemNu Vasive, Incorporated201694—
+5K162264Cascadia Interbody SystemK2m, Inc.2016169—
+5K153665Prow Fusion-LNlt Spine, Ltd.20160—
+5K161081SeaSpine Shoreline ACS - Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation201683—
+5K161888JULIET® LL Lateral Lumbar CageSpineart2016145—
+5K160958Battalion Universal Spacer SystemAlphatec Spine2016114—
+5K160066Pro-Link® Stand-Alone Cervical Spacer SystemLife Spine, Inc.20163—
+5K161230NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated2016381—
+5K153621Juliet® TiSpineart2016751
+5K152622Alta ACDF SystemBiomet Spine20160—
+5K152501Spinal Jaxx Interbody Fusion DeviceNeuropro Spinaljaxx, Inc.201601
+5K160916CoRoent® Ti-C SystemNu Vasive, Incorporated2016139—
+5K161280Cervical Stand Alone SystemOrthofix, Inc.201614—
+5K160522White Pearl Preferred Angle Anterior Cervical PlateOsseus Fusion Systems, LLC20160—
+5K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+5K160051NuVasive® Interfixated Interbody SystemNu Vasive, Incorporated2016396—
+5K153419NuVasive CoRoent Thoracolumbar SystemNu Vasive, Incorporated2016400—
+5K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+5K151665SUSTAIN Additional ImplantsGlobus Medical, Inc.2016119—
+5K153438PERIMETER C (Titanium) Spinal SystemMedtronic Sofamor Danek USA, Inc.20160—
+5K160291Optimus ALIF SystemAmendia, Inc.20160—
+5K153695Biomet Spine Fusion SystemBiomet Spine, LLC201632
+5K153373CORNERSTONE PSR Cervical Fusion System, PERIMETER C Spinal System, PEEK PREVAIL Cervical…Medtronic Sofamor Danek2016110—
+5K152475FORZA PTC Spacer SystemOrthofix, Inc.2016236—
+5K151496Latitude-C Cervical Interbody Spacer SystemDegen Medical201513—
+5K151900VariLift-L Interbody Fusion DeviceWenzel Spine, Inc.20158—
+5K152259InFill Interbody Fusion DevicePinnacle Spine Group, LLC20152—
+5K150788Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral Body Fusion…Meditech Spine, LLC2015202—
+5K151785Px HA PEEK IBF SystemInnovasis, Inc.201557—
+5K143479Bluefin Interbody SystemTides Medical20152—
+5K151727Everest Spinal SystemK2m, Inc.201511—
+5K150619CONSTRUX Mini PEEK Spacer System, CONSTRUX Mini PEEK Ti Spacer SystemOrthofix, Inc.2015107—
+5K151756Sterispine LC CageSafe Orthopaedics20150—
+5K151677LnK Cervical Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20158—
+5K150321EVOS Lumbar Interbody SystemCutting Edge Spine, LLC201592—