510(k) Report

Devices descending from K040482

1,621 later devices reach Ebi Esl Spine Spacer System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K181229TirboLOX-C Cervical IBFDCaptiva Spine, Inc.20180—
+5K181337Sypher Spacer SystemBiogennix, LLC20180—
+5K181655Renovis S180 Lateral Lumbar Interbody Fusion SystemRenovis Surgical Technologies20184—
+5K181483Tranquil Interbody SystemNexus Spine, LLC20186—
+5K181347Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC201824—
+5K180990TirboLOX-L Lumbar IBFDCaptiva Spine, Inc.20181—
+5K180814CoreLink® M3™ Stand-Alone Anterior Lumbar SystemCorelink, LLC201818—
+5K180076Ti 3Z Interbody SystemZavation Medical Products, LLC20184—
+5K180556Corelink Foundation 3D Anterior Lumbar SystemCorelink, LLC20185—
+5K181030Rubicon Lumbar Interbody Fusion SystemRubicon Spine, LLC20180—
+5K180695FBC 921 (Alif)Fbc Device Aps20180—
+5K181246Zavation IBF SystemZavation Medical Products, LLC201822—
+5K180364HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC2018106—
+5K172788MONET™ Anterior Cervical Interbody Fusion Cage SystemCtl Medical Corporation20181—
+5K180674EVOL® ha-C Cervical Interbody Fusion SystemCutting Edge Spine, LLC20183—
+5K180502S128 Anterior Lumbar Interbody Fusion (ALIF) SystemRenovis Surgical Technologies, Inc.201811—
+5K173787X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage System…Medos International SARL20182—
+5K172480icotec Interbody Cage SystemIcotec AG20185—
+5K172484A-CIFT SoloFuseSpinefrontier, Inc.201871
+5K173082Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20185—
+5K173324ALTA Anterior Cervical Interbody SpacerAstura Medical201827—
+5K173077Cavetto-SA Cervical Cage SystemNeurostructures, Inc.201821—
+5K171312FortiCore®Nanovis, LLC20183—
+5K172212MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEK™Ctl Medical Corporation20181—
+5K173159Cervical Spinal Truss System (CSTS) Interbody Fusion Device4Web, Inc.201812—
+5K172926SeaSpine Vu cPOD, Zuma-C, Complete CervicalSeaSpine Orthopedics Corporation201761—
+5K173182ProLift® Expandable SystemLife Spine, Inc.201737—
+5K172676NuVasive® Modulus-C Interbody SystemNu Vasive, Incorporated2017125—
+5K172009Cascadia Interbody SystemK2m, Inc.2017433
+5K172419Velofix™ TLIF CageU&I Corporation20172—
+5K170235Lucent®Spinal Elements, Inc.2017107—
+5K172424Velofix™ SA Cervical CageU&I Corporation201751
+5K172341NuVasive® Modulus TLIF Interbody SystemNu Vasive, Incorporated2017163—
+5K163366Shanghai Sanyou CARMEN Cervical Fusion SystemShanghai Sanyou Medical Co, Ltd.20170—
+5K171633NuVasive TLX Interbody SystemNu Vasive, Incorporated2017251—
+5K171140Matrixx SystemNexxt Spine, LLC2017145—
+5K171075Calix-C Cervical Interbody SpacerX-Spine Systems, Inc.201715—
+5K170503EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular…Eit Emerging Implant Technologies GmbH20171992
+5K161710Sagico Ibf System – Aria Lumbar, Sagico Ibf System – Arion CervicalSpinal Analytics & Geometrical Impant Co, LLC201741—
+5K163481HALF DOME Posterior Lumbar Interbody SystemAstura Medical201731—
+5K163230NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2017276—
+5K163364MOJAVE Expandable Interbody SystemK2m201725—
+5K162446FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK…Orthofix, Inc.20166—
+5K161809ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc.20165—
+5K162103Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine…Choicespine, LP2016161—
+5K161379ELSA SpacersGlobus Medical, Inc.2016155—
+5K161129Pillar SA PTCOrthofix, Inc.201619—
+5K161485Nanovis Intervertebral Body Fusion System and Forticore (R)Nanovis, LLC20165—
+5K161223TransContinental® M Spacers and InterContinental® Plate-SpacersGlobus Medical, Inc.2016117—
+5K153786Prow Fusion-VNlt Spine, Ltd.20166—
+5K153107Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine VEO™…Choicespine, LP2016171—
+5K153615NeoFuse HA Enhanced PLIF/TLIFHt Medical, LLC201650—
+5K160125Cascadia Interbody SystemK2m2016315—
+5K160547Cascadia Interbody SystemK2m2016157—
+5K153782NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated2016390—
+5K153627NuVasive® TLX Interbody SystemNu Vasive, Incorporated2016252—
+5K152568C-VBRCardinal Spine, LLC201657—
+5K151939COALITION SpacersGlobus Medical, Inc.2016152—
+5K152793Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.201629—
+5K152972Amendia Stand-Alone Cervical SystemAmendia, Inc.201632
+5K151481Sahara Stabilization SystemK2m, Inc.20155—
+5K152515TOMCAT Cervical Spinal SystemChoicespine, LP2015108—
+5K153122Endoskeleton (r) TCS SystemTitan Spine, LLC20151061
+5K151934ROI-C Titanium-Coated Implant SystemLdr Spine USA20159—
+5K151596Endoskeleton TCS Interbody Fusion DeviceTitan Spine, LLC20151101
+5K150765LDR Spine ROI-C Cervical Cage SystemLdr Spine USA201559—
+5K151472NuVasive CoRoent Lumbar SystemNu Vasive, Incorporated2015479—
+5K151322Amendia Interbody Fusion DevicesAmendia, Inc.20152261
+5K150481Cascadia Interbody SystemK2m, Inc.20154593
+5K151064Solitaire-C Cervical Spacer System, C-Thru Anterior Spinal System, Breckenridge Small…Biomet Spine201517—
+5K151483Biomet Spine Fusion SystemBiomet Spine, LLC20154—
+5K151198A-CIFT SoloFuseSpinefrontier, Inc.20158—
+5K151184InFill Interbody Fusion DevicesPinnacle Spine Group, LLC20153—
+5K142005SpineFab Vertebral Body Replacement (VBR) SystemOxford Performance Materials201513—
+5K150500Px PEEK IBF SystemInnovasis, Inc.201558—
+5K150994NuVasive CoRoent Thoracolumbar ImplantsNu Vasive, Incorporated2015402—
+5K150362NuVasive CoRoent Small Interbody SystemNu Vasive, Incorporated2015441—
+5K142269Reliance Cervical IBF SystemReliance Medical Systems, LLC201523—
+5K150130Ascendant TM Cervical Spacer SystemExactech, Inc.20157—
+5K142487Chesapeake Stabilization SystemK2m, Inc.201571
+5K150913Incite Anchored Cervical Interbody DeviceIncite Innovation20150—
+5K142392Zavation Posterior LEIFZavation, LLC20150—
+5K143595NuVasive (R) CCX-L Interbody SystemNu Vasive, Incorporated2015253—
+5K143360LnK Cervical Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20159—
+5K142218Coalition AGX Plate and Coalition AGX SpacerGlobus Medical, Inc.2015155—
+5K143214SCARLET® AC-T Secured Anterior Cervical CageSpineart20153—
+5K142030STGC-LordoticCardinal Spine, LLC201558—
+5K141599Divergence Anterior Cervical Fusion SystemMedtronic Sofamor Danek USA, Inc.201516—
+5K142152Construx Mini Peek; Spacer System, TI Spacer System, Cervical Stand Alone SystemOrthofix, Inc.2015280—
+5K142271Zavation Z-Link LumbarZavation, LLC20149—
+5K141135Juliet LLSpineart2014146—
+5K141537IN:C2 Spinal Fixation SystmeSpine Smith Holdings, LLC20140—
+5K133827A-Link ZOsteo Vasive, LLC2014262
+5K142050Nuvasive Coroent Small Contoured Interbody SystemNu Vasive, Incorporated2014449—
+5K141314Scarlet AC-T Secured Anterior Cervical Cage and Associated InstrumentationSpineart201438—
+5K141405Mobis II ST Spinal ImplantSignus Medizintechnik GmbH2014461—
+5K140280ForticoreNanovis, LLC20149—
+5K140921Coroent Small Interbody SystemNu Vasive, Incorporated2014444—
+5K141376Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx, Struxxure Anterior…Nexxt Spine, LLC2014106—
+5K133494Chesapeake Spinal SystemK2m, Inc.2014330—