510(k) Report

Devices descending from K043479

1,214 later devices reach MC+ Partial VBR through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K191537eCarbon IBDsBack 2 Basics Direct, LLC20193—
+1K181591Fixated Asfora BULLET CAGE® (FABC)Medical Designs, LLC20180—
+1K131292Deroyal Spine Spacer SystemDeroyal Industries, Inc.20140—
+1K123758Tasmin RSignus Medizintechnik GmbH20141—
+1K132718Integrity Spine Core SystemIntegrity Spine20131—
+1K123206Maxim Surgical X-Treme Interbody Fusion SystemMaxim Surgical2013454—
+1K123388K7C SpacerK7, LLC20130—
+1K110659Medical Concepts Interbody Fusion SystemMedical Concepts, Inc.20111—
+1K103034Genesys Spine Interbody Fusion SystemGenesys Spine20101371
+1K100042Difusion Technologies Xiphos Interbody Fusion SystemDifusion Technologies2010864—
+1K092540C-PS Peek Optima Cervical Interbody Spacer, L-PS Peek Optima Lumbar Interbody SpacerRsb Spine, LLC201045—
+1K092904Pathway Ivb/VBRCustom Spine, Inc.2009296—
+1K091088LDR Spine Cervical Interbody Fusion SystemLdr Spine USA2009901—
+1K090064Eminent Spine Interbody Fusion SystemEminent Spine20097011
+1K083857LDR Spine Roi-C ImplantLdr Spine USA2009902—
+1K080971Spinesmith Cimplicity Spinal SystemSpine Smith Partners L.P.2008406—
+1K080728LDR Spine Roi-C ImplantLdr Spine USA2008903—
+1K080572LDR Spine Roi-a ImplantLdr Spine USA2008113—
+2K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+2K241438Signus Tetris™ St; Signus Tetris™ R StSignus Medizintechnik GmbH20240—
+2K241396uCerv Flux™-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA, Inc.20240—
+2K233191TotalTi ACDF by SAGICOSpinal Analytics & Geometrical Implant Co, LLC20230—
+2K230478Acro Composites Interbody SystemAcro Composites, LLC20230—
+2K221138Titus Titanium Cervical by SAGICOSagico VA USA, LLC20231—
+2K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+2K230219Eminent Spine 3D Lumbar Interbody Fusion SystemsEminent Spine, LLC20234—
+2K223043The Integrity Spine Core SystemIntegrity Spine20230—
+2K223146EVOLUTION SPINE Interbody SystemEvolution Spine20239—
+2K212701Eminent Spine 3D Cervical Interbody Fusion SystemEminent Spine20235—
+2K203683CarboClear Lumbar Cage SystemCarbofix Orthpedics, Ltd.20211—
+2K200549Lucero Medical Cervical Cage SystemLucero Medical, LLC20200—
+2K202065DOLOMITE Anterior Cervical Stabilization SystemAstura Medical, LLC20203—
+2K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine20207—
+2K182987Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20199—
+2K190544XIHPOS™ ZFUZE™ Interbody Fusion SystemDifusion Technologies20190—
+2K191822Nano FortiCore, FortiCoreNanovis, LLC20192—
+2K190398Republic Spine Restore Intervertebral Body Fusion SystemRepublic Spine, LLC20190—
+2K191354Ti3Z Cervical Interbody SystemZavation Medical Products, LLC201913—
+2K190889Republic Spine Restore Cervical Interbody Fusion SystemRepublic Spine, LLC20190—
+2K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC201993—
+2K182477Cervical SpacerAdditive Implants, LLC201915—
+2K181295Genesys Spine AIS-C Cervical Stand-Alone SystemGenesys Spine201817—
+2K173947Lumbar Interbody Fusion System (OLLIF)Advanced Research Medical, LLC201801
+2K180056Genesys Spine AIS-C Cervical Anchored Interbody SystemGenesys Spine201818—
+2K172320Neurostructures Cavetto® Cervical Cage SystemNeurostructures, Inc.20183—
+2K172330Blustone Synergy Silica SystemBlustone Synergy20170—
+2K173148ACIFColigne AG20171—
+2K171893Blustone Synergy Lumbar Interbody Fusion System (Basalt, Magma, Obsidian), Blustone…Bluestone Synergy20172—
+2K171656Genesys Spine Apache Interbody Fusion SystemGenesys Spine20170—
+2K170844Gemini-C Hybrid Cervical Interbody SystemOsseus Fusion Systems, LLC20170—
+2K170297Tranquil Interbody SystemNexus Spine, LLC201715—
+2K163494Summit Spine Channel Cervical Interbody Fusion SystemSummit Spine20171—
+2K162206Zavation IBFZavation, LLC201724—
+2K160222OIC Cervical PEEK SpacerThe Orthopaedic Implant Company20160—
+2K160663Lumbar Interbody Fusion System (ALIF, PLIF, LLIF, TPLIF)Evolution Spine, LLC20160—
+2K161438Genesys Spine Apache® Anterior Lumbar Interbody Fusion SystemGenesys Spine201611—
+2K152099Genesys Spine Apache® Anchored Cervical Interbody Fusion SystemGenesys Spine201619—
+2K161404Genesys Spine Apache® Lateral Lumbar Interbody Fusion SystemGenesys Spine201610—
+2K160874Nanovis Intervertebral Body Fusion System and FortiCore®Nanovis, LLC20164—
+2K160154ALTA Anterior Cervical Interbody SpacerAstura Medical201663—
+2K160324Cervical Interbody Fusion SystemEvolution Spine, LLC20162—
+2K153123Genesys Spine Apache Interbody Fusion SystemGenesys Spine201612—
+2K152532AERO -C Cervical Cage SystemStryker Spine2015145—
+2K151819Integrity Spine Lumbar Interbody Fusion SystemIntegrity Spine Lumbar Interbody Fusion System20154—
+2K150812Genesys Spine Apache Cervical Interbody Fusion SystemGenesys Spine201512—
+2K150847Foundation Interbody DevicesCorelink, LLC201529—
+2K143572Intersomatic Cervical Device - DICOM PEEK, Intersomatic Intervertebral Space Maintenance…Osteomed Implantes, Ltda20150—
+2K141798Sypher Spacer SystemBiogennix, LLC20151—
+2K142940Endoskeleton TCS SystemTitan Spine, LLC20151112
+2K142328nvcNvision Biomedical Technologies, LLC20144—
+2K142594nva, nvp, nvtNvision Biomedical Technologies, LLC20144—
+2K141333Arena-C Tifuse Cervical Intervertebral Body Fusion DeviceSpinefrontier, Inc.20140—
+2K142026Spinefrontier Arena-C HA Peek Cervical Intervertebral Body Fusion DeviceSpinefrontier, Inc.2014190—
+2K141337Arena-CSpinefrontier, Inc.20141—
+2K141129Exactech Cervical Spacer SystemExactech, Inc.20148—
+2K141005Z-Link CervicalZavation, LLC20144—
+2K133815Intess Cervical Cage SystemKalitec Direct, LLC20144—
+2K132999Cervical Stand Alone SystemOrthofix, Inc.2014281—
+2K140003Coroent Small Interbody SystemNuvasive, Inc.2014453—
+2K132483Innesis Peek Cervical CageBk Meditech, Co., Ltd.20140—
+2K131880Spinefrontier a-Cift Solofuse Cervical Intervertebral Fusion Device SystemSpinefrontier, Inc.201427—
+2K130913Genesys Spine Apache Lateral Lumbar Interbody Fusion SystemGenesys Spine201314—
+2K130317Genesys Spine Apache Ibfd Star Cervical SystemGenesys Spine20139—
+2K133126K7 Lumbar SpacersK7, LLC20131—
+2K132029Vault-C Intervertebral Body Fusion DeviceSpinal USA2013108—
+2K131981Cezanne II Interbody Fusion SystemAccel Spine201354
+2K131082Interform Interbody Cage SystemNext Orthosurgical2013595—
+2K121178Transcorp Acif SystemTranscorp, Inc.20130—
+2K131372Mobis IISignus Medizintechnik GmbH2013462—
+2K122588Vusion CS PlusOrtho Development Corp.2013206—
+2K122518Synster (Cervical,Alif, Plif, Ptlif and Tlif) Cage Hera Cervical Cage Rhea Plif Cage…Bm Korea Co., Ltd.20133—
+2K123969XiphosDifusion Technologies201314—
+2K122630IN:C2 Spinal Fixation SystemSpine Smith Partners L.P.2012405—
+2K122008Incite Anchored Cervical Interbody (Aci) Fusion DeviceIncite Innovation, LLC201210—
+2K120401Alamo TAlliance Partners, LLC20121—
+2K121103LDR Spine Usa Spine Tune, TL Spinal System, LDR Spine Usa Easyspine, Posterior Spinal…Ldr Spine USA, Inc.201216—
+2K121176STGCCardinal Spine, LLC201259—
+2K121320C7 Anterior Cervical Intervertebral Fusion CageMedyssey Co, Ltd.20122—
+2K121569Matisse Anterior Cervical Interbody Fusion Cage SystemAccel Spine20123—
+2K120966Depuy Pulse Lumbar Cage SystemMedos International SARL201225—