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
+4K172341NuVasive® Modulus TLIF Interbody SystemNu Vasive, Incorporated2017163—
+4K163366Shanghai Sanyou CARMEN Cervical Fusion SystemShanghai Sanyou Medical Co, Ltd.20170—
+4K171633NuVasive TLX Interbody SystemNu Vasive, Incorporated2017251—
+4K171496Tritanium C Anterior Cervical CageStryker Spine2017129—
+4K171140Matrixx SystemNexxt Spine, LLC2017145—
+4K171075Calix-C Cervical Interbody SpacerX-Spine Systems, Inc.201715—
+4K170503EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular…Eit Emerging Implant Technologies GmbH20171992
+4K161710Sagico Ibf System – Aria Lumbar, Sagico Ibf System – Arion CervicalSpinal Analytics & Geometrical Impant Co, LLC201741—
+4K163481HALF DOME Posterior Lumbar Interbody SystemAstura Medical201731—
+4K163230NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2017276—
+4K163364MOJAVE Expandable Interbody SystemK2m201725—
+4K162446FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK…Orthofix, Inc.20166—
+4K161809ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc.20165—
+4K162103Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine…Choicespine, LP2016161—
+4K161379ELSA SpacersGlobus Medical, Inc.2016155—
+4K161129Pillar SA PTCOrthofix, Inc.201619—
+4K161485Nanovis Intervertebral Body Fusion System and Forticore (R)Nanovis, LLC20165—
+4K161223TransContinental® M Spacers and InterContinental® Plate-SpacersGlobus Medical, Inc.2016117—
+4K153786Prow Fusion-VNlt Spine, Ltd.20166—
+4K153107Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine VEO™…Choicespine, LP2016171—
+4K153615NeoFuse HA Enhanced PLIF/TLIFHt Medical, LLC201650—
+4K160125Cascadia Interbody SystemK2m2016315—
+4K160547Cascadia Interbody SystemK2m2016157—
+4K153782NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated2016390—
+4K153627NuVasive® TLX Interbody SystemNu Vasive, Incorporated2016252—
+4K152568C-VBRCardinal Spine, LLC201657—
+4K151939COALITION SpacersGlobus Medical, Inc.2016152—
+4K152793Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.201629—
+4K152972Amendia Stand-Alone Cervical SystemAmendia, Inc.201632
+4K151310Amendia Interbody Fusion DevicesAmendia, Inc.2016169—
+4K151481Sahara Stabilization SystemK2m, Inc.20155—
+4K152515TOMCAT Cervical Spinal SystemChoicespine, LP2015108—
+4K153122Endoskeleton (r) TCS SystemTitan Spine, LLC20151061
+4K151934ROI-C Titanium-Coated Implant SystemLdr Spine USA20159—
+4K151596Endoskeleton TCS Interbody Fusion DeviceTitan Spine, LLC20151101
+4K150765LDR Spine ROI-C Cervical Cage SystemLdr Spine USA201559—
+4K151472NuVasive CoRoent Lumbar SystemNu Vasive, Incorporated2015479—
+4K151322Amendia Interbody Fusion DevicesAmendia, Inc.20152261
+4K150481Cascadia Interbody SystemK2m, Inc.20154593
+4K151064Solitaire-C Cervical Spacer System, C-Thru Anterior Spinal System, Breckenridge Small…Biomet Spine201517—
+4K151483Biomet Spine Fusion SystemBiomet Spine, LLC20154—
+4K151198A-CIFT SoloFuseSpinefrontier, Inc.20158—
+4K151184InFill Interbody Fusion DevicesPinnacle Spine Group, LLC20153—
+4K142005SpineFab Vertebral Body Replacement (VBR) SystemOxford Performance Materials201513—
+4K150500Px PEEK IBF SystemInnovasis, Inc.201558—
+4K150994NuVasive CoRoent Thoracolumbar ImplantsNu Vasive, Incorporated2015402—
+4K150362NuVasive CoRoent Small Interbody SystemNu Vasive, Incorporated2015441—
+4K142269Reliance Cervical IBF SystemReliance Medical Systems, LLC201523—
+4K150130Ascendant TM Cervical Spacer SystemExactech, Inc.20157—
+4K142487Chesapeake Stabilization SystemK2m, Inc.201571
+4K150913Incite Anchored Cervical Interbody DeviceIncite Innovation20150—
+4K142392Zavation Posterior LEIFZavation, LLC20150—
+4K143595NuVasive (R) CCX-L Interbody SystemNu Vasive, Incorporated2015253—
+4K143360LnK Cervical Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20159—
+4K142218Coalition AGX Plate and Coalition AGX SpacerGlobus Medical, Inc.2015155—
+4K143214SCARLET® AC-T Secured Anterior Cervical CageSpineart20153—
+4K142030STGC-LordoticCardinal Spine, LLC201558—
+4K141599Divergence Anterior Cervical Fusion SystemMedtronic Sofamor Danek USA, Inc.201516—
+4K142152Construx Mini Peek; Spacer System, TI Spacer System, Cervical Stand Alone SystemOrthofix, Inc.2015280—
+4K142271Zavation Z-Link LumbarZavation, LLC20149—
+4K141135Juliet LLSpineart2014146—
+4K141537IN:C2 Spinal Fixation SystmeSpine Smith Holdings, LLC20140—
+4K133827A-Link ZOsteo Vasive, LLC2014262
+4K142050Nuvasive Coroent Small Contoured Interbody SystemNu Vasive, Incorporated2014449—
+4K141314Scarlet AC-T Secured Anterior Cervical Cage and Associated InstrumentationSpineart201438—
+4K141405Mobis II ST Spinal ImplantSignus Medizintechnik GmbH2014461—
+4K140280ForticoreNanovis, LLC20149—
+4K140921Coroent Small Interbody SystemNu Vasive, Incorporated2014444—
+4K141376Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx, Struxxure Anterior…Nexxt Spine, LLC2014106—
+4K133494Chesapeake Spinal SystemK2m, Inc.2014330—
+4K140529Everest Spinal SystemK2m, LLC201431—
+4K140303Alamo TAlliance Partners, LLC20140—
+4K132596Proposed OptimusCustom Spine, Inc.201451
+4K133340Spineworks Anterior Lumbar DeviceSpineworks, LLC201413—
+4K133614Aleutian Ibf SystemK2m, Inc.2014527—
+4K140106S128 Anterior Lumbar Interbody Fusion (Alif) SystemRenovis Surgical Technologies, Inc.2014265—
+4K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—
+4K133529Camber Spine Coveris Cervical CageCamber Spine201410—
+4K132991C-Box Peek Cervical IbfInnovasis, Inc.20149—
+4K132582Exactech Acapella One Cervical Spacer SystemExactech, Inc.2014471
+4K133557Juliet LL Lateral Lumbar CageSpineart2014147—
+4K132894Optio-C Anterior Cervical SystemZimmer Spine, Inc.201424—
+4K132584Perimeter C Spinal SystemMedtronic Sofamor Danek USA, Inc.2013119—
+4K132757Everest Spinal SystemK2m, Inc.201341—
+4K130853Idys (TM) CClariance20132—
+4K131350Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc.2013214
+4K131178Idys Lif CagesClariance201311—
+4K132361Everest Spinal SystemK2m, Inc.201334—
+4K130948C-Fuse Cervical Intervertebral Body Fusion SystemSouthern Spine, LLC201313—
+4K131077Life Spine Plateau Spacer SystemLife Spine201310—
+4K131671MectalifMedacta International201322—
+4K130699Aleutian Spinal SystemK2m, Inc.2013570—
+4K122801Providence Cervical CageProvidence Medical Technology, Inc.20131—
+4K130506Imse P-TlifInstitute of Musculoskeletal Science & Education20130—
+4K130306Incite Anchored Cervical Interbody DeviceIncite Innovation, LLC20131—
+4K122037Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion System Peek Prevail…Medtronic Sofamor Danek, Inc.2013281—
+4K123767Lanx Fusion System- SALanx, Inc.20133244
+4K123993Solus Anterior Lumbar Interbody Fusion (Alif) SystemAlphatec Spine, Inc.20130—
+4K122872Intervertebral Body Fusion DeviceDio Medical Co., Ltd.201316—
+4K120603Varilift -CWenzel Spine2013193—