510(k) Report

Devices descending from K090064

701 later devices reach Eminent Spine Interbody Fusion System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K230219Eminent Spine 3D Lumbar Interbody Fusion SystemsEminent Spine, LLC20234—
+1K212701Eminent Spine 3D Cervical Interbody Fusion SystemEminent Spine20235—
+1K190398Republic Spine Restore Intervertebral Body Fusion SystemRepublic Spine, LLC20190—
+1K190889Republic Spine Restore Cervical Interbody Fusion SystemRepublic Spine, LLC20190—
+1K173947Lumbar Interbody Fusion System (OLLIF)Advanced Research Medical, LLC201801
+1K172320Neurostructures Cavetto® Cervical Cage SystemNeurostructures, Inc.20183—
+1K172330Blustone Synergy Silica SystemBlustone Synergy20170—
+1K171893Blustone Synergy Lumbar Interbody Fusion System (Basalt, Magma, Obsidian), Blustone…Bluestone Synergy20172—
+1K163494Summit Spine Channel Cervical Interbody Fusion SystemSummit Spine20171—
+1K160663Lumbar Interbody Fusion System (ALIF, PLIF, LLIF, TPLIF)Evolution Spine, LLC20160—
+1K160874Nanovis Intervertebral Body Fusion System and FortiCore®Nanovis, LLC20164—
+1K160324Cervical Interbody Fusion SystemEvolution Spine, LLC20162—
+1K150812Genesys Spine Apache Cervical Interbody Fusion SystemGenesys Spine201512—
+1K150847Foundation Interbody DevicesCorelink, LLC201529—
+1K141333Arena-C Tifuse Cervical Intervertebral Body Fusion DeviceSpinefrontier, Inc.20140—
+1K142026Spinefrontier Arena-C HA Peek Cervical Intervertebral Body Fusion DeviceSpinefrontier, Inc.2014190—
+1K141337Arena-CSpinefrontier, Inc.20141—
+1K141129Exactech Cervical Spacer SystemExactech, Inc.20148—
+1K131292Deroyal Spine Spacer SystemDeroyal Industries, Inc.20140—
+1K130317Genesys Spine Apache Ibfd Star Cervical SystemGenesys Spine20139—
+1K133126K7 Lumbar SpacersK7, LLC20131—
+1K132718Integrity Spine Core SystemIntegrity Spine20131—
+1K131981Cezanne II Interbody Fusion SystemAccel Spine201354
+1K121178Transcorp Acif SystemTranscorp, Inc.20130—
+1K131372Mobis IISignus Medizintechnik GmbH2013462—
+1K122518Synster (Cervical,Alif, Plif, Ptlif and Tlif) Cage Hera Cervical Cage Rhea Plif Cage…Bm Korea Co., Ltd.20133—
+1K123969XiphosDifusion Technologies201314—
+1K123206Maxim Surgical X-Treme Interbody Fusion SystemMaxim Surgical2013454—
+1K123388K7C SpacerK7, LLC20130—
+1K111820Synster Cervical Cage, Alif Cage, Plif Cage, Ptlif Cage, Tlif CageBm Korea Co., Ltd.201220—
+1K113518Arena-C Cervical Intervertebral Body Fusion SystemSpinefrontier, Inc.2012193—
+1K110659Medical Concepts Interbody Fusion SystemMedical Concepts, Inc.20111—
+1K110177Helena SystemRoyal Oak Medical Devices20110—
+1K103034Genesys Spine Interbody Fusion SystemGenesys Spine20101371
+2K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+2K253260ORIO-3D Cage SystemSpineCraft20260—
+2K252219Cervical Interbody and VBR Fusion SystemSync Surgical20260—
+2K243074Spectrum Spine Lumbar Cage SystemSpectrum Spine, Inc.20252—
+2K231715MONDRIAN™ Anterior Lumbar Plate SystemCtl Medical Corporation20240—
+2K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+2K230607SPICCA Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+2K223043The Integrity Spine Core SystemIntegrity Spine20230—
+2K223146EVOLUTION SPINE Interbody SystemEvolution Spine20239—
+2K212389Advantage Lumbar System - ALIF, PLIF, DLIF, TLIFIntelivation, LLC20210—
+2K210382Blustone Synergy Diamond SA Cervical SystemBlustone Synergy, LLC20210—
+2K203520Blustone Synergy Interbody Fusion SystemBlustone Synergy, LLC20210—
+2K201643ChoiceSpine Tiger Shark Cervical Spacer SystemChoice Spine, LLC20204—
+2K201769Cavetto [MAX] Cervical Cage SystemNeurostructures, Inc.20200—
+2K192863MONDRIAN Lumbar Interbody Fusion Cage SystemCtl Medical Corporation20203—
+2K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine20207—
+2K182987Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20199—
+2K1803473d CageFims Co., Ltd.20190—
+2K191822Nano FortiCore, FortiCoreNanovis, LLC20192—
+2K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer…Choice Spine, LLC20194—
+2K190618RIGEL PEEK Anterior Cervical Interbody Fusion SystemMiRus, LLC20191—
+2K183239CoreLink F3D™ Lateral SystemCorelink, LLC20188—
+2K181590Neurostructures Cavetto® [MAX] Cervical Cage SystemNeurostructures, Inc.20180—
+2K181295Genesys Spine AIS-C Cervical Stand-Alone SystemGenesys Spine201817—
+2K180814CoreLink® M3™ Stand-Alone Anterior Lumbar SystemCorelink, LLC201818—
+2K180556Corelink Foundation 3D Anterior Lumbar SystemCorelink, LLC20185—
+2K180674EVOL® ha-C Cervical Interbody Fusion SystemCutting Edge Spine, LLC20183—
+2K172484A-CIFT SoloFuseSpinefrontier, Inc.201871
+2K180056Genesys Spine AIS-C Cervical Anchored Interbody SystemGenesys Spine201818—
+2K173324ALTA Anterior Cervical Interbody SpacerAstura Medical201827—
+2K171312FortiCore®Nanovis, LLC20183—
+2K172419Velofix™ TLIF CageU&I Corporation20172—
+2K171656Genesys Spine Apache Interbody Fusion SystemGenesys Spine20170—
+2K170243LOSPA IS TLIF & DLIF CagesCorentec Co., Ltd.20170—
+2K161809ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc.20165—
+2K161438Genesys Spine Apache® Anterior Lumbar Interbody Fusion SystemGenesys Spine201611—
+2K161404Genesys Spine Apache® Lateral Lumbar Interbody Fusion SystemGenesys Spine201610—
+2K153615NeoFuse HA Enhanced PLIF/TLIFHt Medical, LLC201650—
+2K153123Genesys Spine Apache Interbody Fusion SystemGenesys Spine201612—
+2K152515TOMCAT Cervical Spinal SystemChoicespine, LP2015108—
+2K142269Reliance Cervical IBF SystemReliance Medical Systems, LLC201523—
+2K150130Ascendant TM Cervical Spacer SystemExactech, Inc.20157—
+2K141798Sypher Spacer SystemBiogennix, LLC20151—
+2K142328nvcNvision Biomedical Technologies, LLC20144—
+2K142594nva, nvp, nvtNvision Biomedical Technologies, LLC20144—
+2K141405Mobis II ST Spinal ImplantSignus Medizintechnik GmbH2014461—
+2K133340Spineworks Anterior Lumbar DeviceSpineworks, LLC201413—
+2K140003Coroent Small Interbody SystemNuvasive, Inc.2014453—
+2K132483Innesis Peek Cervical CageBk Meditech, Co., Ltd.20140—
+2K130913Genesys Spine Apache Lateral Lumbar Interbody Fusion SystemGenesys Spine201314—
+2K122872Intervertebral Body Fusion DeviceDio Medical Co., Ltd.201316—
+2K120401Alamo TAlliance Partners, LLC20121—
+2K120966Depuy Pulse Lumbar Cage SystemMedos International SARL201225—
+2K120024Mectalif TransforaminalMedacta International S.A.201223—
+3K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine20260—
+3K253377Expandable Titanium PLIF/TLIF SystemSpectrum Spine, Inc.20250—
+3K250605EVOL® ha – Hyper C Cervical Interbody Fusion SystemCutting Edge Spine, LLC20250—
+3K242483Genesys Spine AIS-C II Cervical Interbody Fusion SystemGenesys Spine20250—
+3K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc.20241—
+3K241438Signus Tetris™ St; Signus Tetris™ R StSignus Medizintechnik GmbH20240—
+3K241605Adaptix™ PEEK Interbody System with Nanotechnology; Capstone Control™ PEEK Spinal System…Nanovis, LLC20240—
+3K241846E3D™-C Interbody SystemEvolution Spine20246—
+3K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+3K240368E3D™-A Interbody SystemEvolution Spine20247—
+3K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+3K232432E3D™-A Interbody SystemEvolution Spine20248—