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
+1K122989Biomet Lateral Spacer SystemBiomet Spine (Aka Ebi, LLC)2012171—
+1K112014Zyston Straight Spacer SystemBiomet Spine2011174—
+1K042268Ebi Cas Spine Spacer SystemEbi, L.P.20041,620—
+2K233375Tranquil-L Interbody SystemNexus Spine, LLC20240—
+2K170119Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc.201711
+2K151310Amendia Interbody Fusion DevicesAmendia, Inc.2016169—
+2K091381Ibex Spinal SystemEbi, L.P.2009181—
+2K071274Gso GS1 SpacerGold Standard Orthopedics, LLC20070—
+2K052384Lanx VBR SystemLanx, LLC2005455—
+2K043479MC+ Partial VBRLdr Spine USA20051,214—
+2K043349Open Radiotransparent Intersomatic Implant (Roi)Ldr Spine USA2005134—
+2K043206Pioneer Vertebral Body Replacement Device (Pioneer Vertebral Spacer)Pioneer Surgical Technology20051,571—
+2K042714Fidji-Vertebral Body Replacement Type 1, 2, 3 and 4Spine Next America Corporation2004838—
+2K042930Spacevision Cage SystemSpine Vision, Inc.20041,440—
+3K210044Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System…Spinal Elements, Inc.20211—
+3K203520Blustone Synergy Interbody Fusion SystemBlustone Synergy, LLC20210—
+3K191537eCarbon IBDsBack 2 Basics Direct, LLC20193—
+3K182920MiRus™ Lumbar Interbody Fusion System consisting of CALLISTO™ PEEK Posterior Lumbar…MiRus, LLC20199—
+3K181591Fixated Asfora BULLET CAGE® (FABC)Medical Designs, LLC20180—
+3K170643Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) SystemRti Surgical, Inc. Dba Rti Biologics201711—
+3K160924Amendia Interbody Fusion DevicesAmendia, Inc.2016166—
+3K151408LOSPA IS Spinal SystemCorentec Co., Ltd.20151—
+3K150521Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) SystemRti Surgical, Inc. Dba Rti Biologics201512—
+3K132907Plif Lite and Tlif LiteSintea Plustek20140—
+3K133455Crossfuse II Coronal Taper, Crossfuse II HyperlordoticPioneer Surgical Technology, Inc.20145961
+3K133623C-PLUSPioneer Surgical Technology, Inc.2014598—
+3K131292Deroyal Spine Spacer SystemDeroyal Industries, Inc.20140—
+3K123758Tasmin RSignus Medizintechnik GmbH20141—
+3K132718Integrity Spine Core SystemIntegrity Spine20131—
+3K123206Maxim Surgical X-Treme Interbody Fusion SystemMaxim Surgical2013454—
+3K123388K7C SpacerK7, LLC20130—
+3K121103LDR Spine Usa Spine Tune, TL Spinal System, LDR Spine Usa Easyspine, Posterior Spinal…Ldr Spine USA, Inc.201216—
+3K112496Pioneer Crossfuse II Ibf/VBR SystemPioneer Surgical Technology, Inc.2011604—
+3K110659Medical Concepts Interbody Fusion SystemMedical Concepts, Inc.20111—
+3K110650Zyston Arc Interbody SpacerBiomet Spine (Aka Ebi, LLC)2011177—
+3K103034Genesys Spine Interbody Fusion SystemGenesys Spine20101371
+3K100042Difusion Technologies Xiphos Interbody Fusion SystemDifusion Technologies2010864—
+3K092540C-PS Peek Optima Cervical Interbody Spacer, L-PS Peek Optima Lumbar Interbody SpacerRsb Spine, LLC201045—
+3K092904Pathway Ivb/VBRCustom Spine, Inc.2009296—
+3K091088LDR Spine Cervical Interbody Fusion SystemLdr Spine USA2009901—
+3K083815Lanx Fusion SystemLanx, Inc.2009451—
+3K090064Eminent Spine Interbody Fusion SystemEminent Spine20097011
+3K083857LDR Spine Roi-C ImplantLdr Spine USA2009902—
+3K081383Reliance VBS SystemReliance Medical Systems, LLC20080—
+3K080971Spinesmith Cimplicity Spinal SystemSpine Smith Partners L.P.2008406—
+3K072326Ostapek VBR SystemCo-Ligne AG20081—
+3K080728LDR Spine Roi-C ImplantLdr Spine USA2008903—
+3K080569LDR Spine Roi-T ImplantLdr Spine USA20080—
+3K080572LDR Spine Roi-a ImplantLdr Spine USA2008113—
+3K063637Reliance VBS SystemReliance Medical Systems, LLC20071—
+3K072132LDR Spine Roi-T SystemLdr Spine USA20071—
+3K063464Atlas Spine Vertebral Body ReplacementAtlas Spine, Inc.20072—
+3K062759Paramount VBR SystemInnovative Spinal Technologies, Inc.20071,406—
+3K061752Spinal Usa VBR SystemSpinal USA20060—
+3K061151Pioneer Vertebral Spacer (Vertebral Spacer)Pioneer Surgical Technology2006801—
+3K051454Aleutian Spacer SystemK2m, LLC2005666—
+3K051246Construx Mini Peek VBR SystemBlackstone Medical, Inc.2005834—
+4K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+4K241438Signus Tetris™ St; Signus Tetris™ R StSignus Medizintechnik GmbH20240—
+4K241396uCerv Flux™-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA, Inc.20240—
+4K233191TotalTi ACDF by SAGICOSpinal Analytics & Geometrical Implant Co, LLC20230—
+4K230478Acro Composites Interbody SystemAcro Composites, LLC20230—
+4K230607SPICCA Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+4K221138Titus Titanium Cervical by SAGICOSagico VA USA, LLC20231—
+4K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+4K230219Eminent Spine 3D Lumbar Interbody Fusion SystemsEminent Spine, LLC20234—
+4K223043The Integrity Spine Core SystemIntegrity Spine20230—
+4K223146EVOLUTION SPINE Interbody SystemEvolution Spine20239—
+4K212701Eminent Spine 3D Cervical Interbody Fusion SystemEminent Spine20235—
+4K213493Fortilink with TiPlus TechnologyParadigm Spine20220—
+4K203683CarboClear Lumbar Cage SystemCarbofix Orthpedics, Ltd.20211—
+4K200549Lucero Medical Cervical Cage SystemLucero Medical, LLC20200—
+4K202034aprevo Intervertebral Body Fusion DeviceCarlsmed, Inc.202017—
+4K202065DOLOMITE Anterior Cervical Stabilization SystemAstura Medical, LLC20203—
+4K191906MiRus 3D Printed Lumbar Interbody Fusion Systems consisting of the Callisto 3D Printed…MiRus, LLC20206—
+4K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine20207—
+4K182987Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20199—
+4K190544XIHPOS™ ZFUZE™ Interbody Fusion SystemDifusion Technologies20190—
+4K191822Nano FortiCore, FortiCoreNanovis, LLC20192—
+4K190398Republic Spine Restore Intervertebral Body Fusion SystemRepublic Spine, LLC20190—
+4K191354Ti3Z Cervical Interbody SystemZavation Medical Products, LLC201913—
+4K190889Republic Spine Restore Cervical Interbody Fusion SystemRepublic Spine, LLC20190—
+4K190618RIGEL PEEK Anterior Cervical Interbody Fusion SystemMiRus, LLC20191—
+4K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC201993—
+4K183184FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.201912—
+4K182477Cervical SpacerAdditive Implants, LLC201915—
+4K180822VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion SystemWenzel Spine, Inc.20195—
+4K173893TrabisColigne AG20180—
+4K181295Genesys Spine AIS-C Cervical Stand-Alone SystemGenesys Spine201817—
+4K173947Lumbar Interbody Fusion System (OLLIF)Advanced Research Medical, LLC201801
+4K180056Genesys Spine AIS-C Cervical Anchored Interbody SystemGenesys Spine201818—
+4K172320Neurostructures Cavetto® Cervical Cage SystemNeurostructures, Inc.20183—
+4K172330Blustone Synergy Silica SystemBlustone Synergy20170—
+4K173148ACIFColigne AG20171—
+4K172392Lateral Spinal Truss System (LSTS) Interbody Fusion Device4Web, Inc.20171—
+4K172343Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D TechnologyRti Surgical, Inc.201710—
+4K171893Blustone Synergy Lumbar Interbody Fusion System (Basalt, Magma, Obsidian), Blustone…Bluestone Synergy20172—
+4K171351Posterior Spine Truss System (PSTS) Interbody Fusion Device4Web, Inc.20177—
+4K171496Tritanium C Anterior Cervical CageStryker Spine2017129—
+4K170851Anterior Spine Truss System (STS) Interbody Fusion Device4Web, Inc.20175—