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
+1K091381Ibex Spinal SystemEbi, L.P.2009181—
+1K071274Gso GS1 SpacerGold Standard Orthopedics, LLC20070—
+1K052384Lanx VBR SystemLanx, LLC2005455—
+1K043479MC+ Partial VBRLdr Spine USA20051,214—
+1K043349Open Radiotransparent Intersomatic Implant (Roi)Ldr Spine USA2005134—
+1K043206Pioneer Vertebral Body Replacement Device (Pioneer Vertebral Spacer)Pioneer Surgical Technology20051,571—
+1K042714Fidji-Vertebral Body Replacement Type 1, 2, 3 and 4Spine Next America Corporation2004838—
+1K042930Spacevision Cage SystemSpine Vision, Inc.20041,440—
+2K191537eCarbon IBDsBack 2 Basics Direct, LLC20193—
+2K181591Fixated Asfora BULLET CAGE® (FABC)Medical Designs, LLC20180—
+2K170643Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) SystemRti Surgical, Inc. Dba Rti Biologics201711—
+2K151408LOSPA IS Spinal SystemCorentec Co., Ltd.20151—
+2K150521Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) SystemRti Surgical, Inc. Dba Rti Biologics201512—
+2K132907Plif Lite and Tlif LiteSintea Plustek20140—
+2K133455Crossfuse II Coronal Taper, Crossfuse II HyperlordoticPioneer Surgical Technology, Inc.20145961
+2K133623C-PLUSPioneer Surgical Technology, Inc.2014598—
+2K131292Deroyal Spine Spacer SystemDeroyal Industries, Inc.20140—
+2K123758Tasmin RSignus Medizintechnik GmbH20141—
+2K132718Integrity Spine Core SystemIntegrity Spine20131—
+2K123206Maxim Surgical X-Treme Interbody Fusion SystemMaxim Surgical2013454—
+2K123388K7C SpacerK7, LLC20130—
+2K121103LDR Spine Usa Spine Tune, TL Spinal System, LDR Spine Usa Easyspine, Posterior Spinal…Ldr Spine USA, Inc.201216—
+2K112014Zyston Straight Spacer SystemBiomet Spine2011174—
+2K112496Pioneer Crossfuse II Ibf/VBR SystemPioneer Surgical Technology, Inc.2011604—
+2K110659Medical Concepts Interbody Fusion SystemMedical Concepts, Inc.20111—
+2K110650Zyston Arc Interbody SpacerBiomet Spine (Aka Ebi, LLC)2011177—
+2K103034Genesys Spine Interbody Fusion SystemGenesys Spine20101371
+2K100042Difusion Technologies Xiphos Interbody Fusion SystemDifusion Technologies2010864—
+2K092540C-PS Peek Optima Cervical Interbody Spacer, L-PS Peek Optima Lumbar Interbody SpacerRsb Spine, LLC201045—
+2K092904Pathway Ivb/VBRCustom Spine, Inc.2009296—
+2K091088LDR Spine Cervical Interbody Fusion SystemLdr Spine USA2009901—
+2K083815Lanx Fusion SystemLanx, Inc.2009451—
+2K090064Eminent Spine Interbody Fusion SystemEminent Spine20097011
+2K083857LDR Spine Roi-C ImplantLdr Spine USA2009902—
+2K081383Reliance VBS SystemReliance Medical Systems, LLC20080—
+2K080971Spinesmith Cimplicity Spinal SystemSpine Smith Partners L.P.2008406—
+2K072326Ostapek VBR SystemCo-Ligne AG20081—
+2K080728LDR Spine Roi-C ImplantLdr Spine USA2008903—
+2K080569LDR Spine Roi-T ImplantLdr Spine USA20080—
+2K080572LDR Spine Roi-a ImplantLdr Spine USA2008113—
+2K063637Reliance VBS SystemReliance Medical Systems, LLC20071—
+2K072132LDR Spine Roi-T SystemLdr Spine USA20071—
+2K063464Atlas Spine Vertebral Body ReplacementAtlas Spine, Inc.20072—
+2K062759Paramount VBR SystemInnovative Spinal Technologies, Inc.20071,406—
+2K061752Spinal Usa VBR SystemSpinal USA20060—
+2K061151Pioneer Vertebral Spacer (Vertebral Spacer)Pioneer Surgical Technology2006801—
+2K051454Aleutian Spacer SystemK2m, LLC2005666—
+2K051246Construx Mini Peek VBR SystemBlackstone Medical, Inc.2005834—
+3K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+3K241438Signus Tetris™ St; Signus Tetris™ R StSignus Medizintechnik GmbH20240—
+3K241396uCerv Flux™-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA, Inc.20240—
+3K233191TotalTi ACDF by SAGICOSpinal Analytics & Geometrical Implant Co, LLC20230—
+3K230478Acro Composites Interbody SystemAcro Composites, LLC20230—
+3K221138Titus Titanium Cervical by SAGICOSagico VA USA, LLC20231—
+3K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+3K230219Eminent Spine 3D Lumbar Interbody Fusion SystemsEminent Spine, LLC20234—
+3K223043The Integrity Spine Core SystemIntegrity Spine20230—
+3K223146EVOLUTION SPINE Interbody SystemEvolution Spine20239—
+3K212701Eminent Spine 3D Cervical Interbody Fusion SystemEminent Spine20235—
+3K213493Fortilink with TiPlus TechnologyParadigm Spine20220—
+3K203683CarboClear Lumbar Cage SystemCarbofix Orthpedics, Ltd.20211—
+3K200549Lucero Medical Cervical Cage SystemLucero Medical, LLC20200—
+3K202034aprevo Intervertebral Body Fusion DeviceCarlsmed, Inc.202017—
+3K202065DOLOMITE Anterior Cervical Stabilization SystemAstura Medical, LLC20203—
+3K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine20207—
+3K182987Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20199—
+3K190544XIHPOS™ ZFUZE™ Interbody Fusion SystemDifusion Technologies20190—
+3K191822Nano FortiCore, FortiCoreNanovis, LLC20192—
+3K190398Republic Spine Restore Intervertebral Body Fusion SystemRepublic Spine, LLC20190—
+3K191354Ti3Z Cervical Interbody SystemZavation Medical Products, LLC201913—
+3K190889Republic Spine Restore Cervical Interbody Fusion SystemRepublic Spine, LLC20190—
+3K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC201993—
+3K182477Cervical SpacerAdditive Implants, LLC201915—
+3K173893TrabisColigne AG20180—
+3K181295Genesys Spine AIS-C Cervical Stand-Alone SystemGenesys Spine201817—
+3K173947Lumbar Interbody Fusion System (OLLIF)Advanced Research Medical, LLC201801
+3K180056Genesys Spine AIS-C Cervical Anchored Interbody SystemGenesys Spine201818—
+3K172320Neurostructures Cavetto® Cervical Cage SystemNeurostructures, Inc.20183—
+3K172330Blustone Synergy Silica SystemBlustone Synergy20170—
+3K173148ACIFColigne AG20171—
+3K172343Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D TechnologyRti Surgical, Inc.201710—
+3K170119Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc.201711
+3K171893Blustone Synergy Lumbar Interbody Fusion System (Basalt, Magma, Obsidian), Blustone…Bluestone Synergy20172—
+3K171656Genesys Spine Apache Interbody Fusion SystemGenesys Spine20170—
+3K170844Gemini-C Hybrid Cervical Interbody SystemOsseus Fusion Systems, LLC20170—
+3K170297Tranquil Interbody SystemNexus Spine, LLC201715—
+3K163494Summit Spine Channel Cervical Interbody Fusion SystemSummit Spine20171—
+3K163673Fortilink™-C with TETRAfuse™ 3D TechnologyRti Surgical, Inc.201711—
+3K162206Zavation IBFZavation, LLC201724—
+3K170243LOSPA IS TLIF & DLIF CagesCorentec Co., Ltd.20170—
+3K163474CAVUX CervicalCage-L SA SystemProvidence Medical Technology, Inc.20170—
+3K160222OIC Cervical PEEK SpacerThe Orthopaedic Implant Company20160—
+3K160663Lumbar Interbody Fusion System (ALIF, PLIF, LLIF, TPLIF)Evolution Spine, LLC20160—
+3K161438Genesys Spine Apache® Anterior Lumbar Interbody Fusion SystemGenesys Spine201611—
+3K152099Genesys Spine Apache® Anchored Cervical Interbody Fusion SystemGenesys Spine201619—
+3K161404Genesys Spine Apache® Lateral Lumbar Interbody Fusion SystemGenesys Spine201610—
+3K160874Nanovis Intervertebral Body Fusion System and FortiCore®Nanovis, LLC20164—
+3K160154ALTA Anterior Cervical Interbody SpacerAstura Medical201663—
+3K160324Cervical Interbody Fusion SystemEvolution Spine, LLC20162—
+3K153123Genesys Spine Apache Interbody Fusion SystemGenesys Spine201612—