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
+3K152532AERO -C Cervical Cage SystemStryker Spine2015145—
+3K151819Integrity Spine Lumbar Interbody Fusion SystemIntegrity Spine Lumbar Interbody Fusion System20154—
+3K150812Genesys Spine Apache Cervical Interbody Fusion SystemGenesys Spine201512—
+3K150847Foundation Interbody DevicesCorelink, LLC201529—
+3K143572Intersomatic Cervical Device - DICOM PEEK, Intersomatic Intervertebral Space Maintenance…Osteomed Implantes, Ltda20150—
+3K141665NuVasive CoRoent SystemNuvasive, Inc.2015588—
+3K142634Biomet Spine Fusion SystemBiomet Spine, LLC20155—
+3K141798Sypher Spacer SystemBiogennix, LLC20151—
+3K142940Endoskeleton TCS SystemTitan Spine, LLC20151112
+3K142328nvcNvision Biomedical Technologies, LLC20144—
+3K142594nva, nvp, nvtNvision Biomedical Technologies, LLC20144—
+3K141333Arena-C Tifuse Cervical Intervertebral Body Fusion DeviceSpinefrontier, Inc.20140—
+3K142026Spinefrontier Arena-C HA Peek Cervical Intervertebral Body Fusion DeviceSpinefrontier, Inc.2014190—
+3K141337Arena-CSpinefrontier, Inc.20141—
+3K141129Exactech Cervical Spacer SystemExactech, Inc.20148—
+3K141005Z-Link CervicalZavation, LLC20144—
+3K140142Choice Spine Lumbar Spacer System (Sabre, Shark, Hornet, Harpoon)Choicespine, LP2014172—
+3K133815Intess Cervical Cage SystemKalitec Direct, LLC20144—
+3K132999Cervical Stand Alone SystemOrthofix, Inc.2014281—
+3K140003Coroent Small Interbody SystemNuvasive, Inc.2014453—
+3K132483Innesis Peek Cervical CageBk Meditech, Co., Ltd.20140—
+3K131880Spinefrontier a-Cift Solofuse Cervical Intervertebral Fusion Device SystemSpinefrontier, Inc.201427—
+3K131724Pioneer Maxfuse Vertebral Body Replacement DevicePioneer Surgical Technology, Inc.201373—
+3K130913Genesys Spine Apache Lateral Lumbar Interbody Fusion SystemGenesys Spine201314—
+3K130317Genesys Spine Apache Ibfd Star Cervical SystemGenesys Spine20139—
+3K133126K7 Lumbar SpacersK7, LLC20131—
+3K132029Vault-C Intervertebral Body Fusion DeviceSpinal USA2013108—
+3K131981Cezanne II Interbody Fusion SystemAccel Spine201354
+3K131122S128 Anterior Lumbar Interbody Fusion (Alif) SystemRenovis Surgical Technologies, LLC2013269—
+3K131082Interform Interbody Cage SystemNext Orthosurgical2013595—
+3K121178Transcorp Acif SystemTranscorp, Inc.20130—
+3K131372Mobis IISignus Medizintechnik GmbH2013462—
+3K122588Vusion CS PlusOrtho Development Corp.2013206—
+3K122518Synster (Cervical,Alif, Plif, Ptlif and Tlif) Cage Hera Cervical Cage Rhea Plif Cage…Bm Korea Co., Ltd.20133—
+3K123969XiphosDifusion Technologies201314—
+3K123134Easyspine SystemLdr Spine USA, Inc.20131—
+3K122630IN:C2 Spinal Fixation SystemSpine Smith Partners L.P.2012405—
+3K122008Incite Anchored Cervical Interbody (Aci) Fusion DeviceIncite Innovation, LLC201210—
+3K122989Biomet Lateral Spacer SystemBiomet Spine (Aka Ebi, LLC)2012171—
+3K120401Alamo TAlliance Partners, LLC20121—
+3K121176STGCCardinal Spine, LLC201259—
+3K121320C7 Anterior Cervical Intervertebral Fusion CageMedyssey Co, Ltd.20122—
+3K121569Matisse Anterior Cervical Interbody Fusion Cage SystemAccel Spine20123—
+3K120966Depuy Pulse Lumbar Cage SystemMedos International SARL201225—
+3K120345Honour Spacer SystemNexxt Spine, LLC2012212—
+3K120840Lexus Cervical Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd.201214—
+3K121116Plateau Spacer SystemLife Spine201213—
+3K120517Depuy Pulse Cervical Cage SystemMedos International SARL20123—
+3K120656Everest Spinal SystemK2m, Inc.201243—
+3K120576Zavation Ibf SystemZavation, LLC201232—
+3K111820Synster Cervical Cage, Alif Cage, Plif Cage, Ptlif Cage, Tlif CageBm Korea Co., Ltd.201220—
+3K120024Mectalif TransforaminalMedacta International S.A.201223—
+3K113518Arena-C Cervical Intervertebral Body Fusion SystemSpinefrontier, Inc.2012193—
+3K113138Aleutian SystemK2m, Inc.2012549—
+3K113559LDR Spine Cervical Interbody Fusion Systme-Roi-C Lordotic ImplantsLdr Spine USA, Inc.2011383—
+3K112664Zavation Ibf SystemsZavation, LLC201137—
+3K111123Varilift Cervical Interbody Fusion SystemWenzel Spine2011196—
+3K110442Nanovis Intervertebral Body Fusion SystemNanovis, LLC201110—
+3K111512Bonebac T-Plif Intervertebral Body Fusion Device SystemThompson Mis, Inc.2011762—
+3K111484DiscoveryIntuitive Spine, LLC20111—
+3K111439Chesapeake (Cervical Components)K2m, Inc.20113451
+3K110843Aleutian Spacer SystemK2m, Inc.2011589—
+3K102606Avs Anchor-C Cervical Cage SystemStryker Spine20113841
+3K110177Helena SystemRoyal Oak Medical Devices20110—
+3K102402Solus Anterior Lumbar Interbody Fusion (Alif) Spinal Spacer SystemAlphatec Spine, Inc.20111121
+3K103666Lanx LateralLanx, Inc.2011238—
+3K100698STCCCardinal Spine, LLC2011346—
+3K103660Lanx Cervical Intervertebral Body Fusion SystemLanx, Inc.201141—
+3K102738Lanx Fusion SystemLanx, LLC20113281
+3K101363VU Cpod Intervertebral Bodu Fusion DeviceMusculoskeletal Clinical Regulatory Advisers201078—
+3K101812Construx Mini Peek Spacer SystemOrthofix, Inc.2010291—
+3K100214Cornerstone PSR Cervical Interbody Fusion DeviceMedtronic Sofamor Danek2010389—
+3K092211Chesapeake Spinal SystemK2m, Inc.2010450—
+3K092774Atlas Intervertebral Body CageSpinal Edge, LLC20100—
+3K082698Aleutian Ibf SystemK2m, Inc.2009662—
+3K081880Atlas Spine SpacerAtlas Spine, Inc.20080—
+3K081849Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc.20087531
+3K073177Pioneer Intervertebral Fusion Device SystemPioneer Surgical Technology20087751
+3K072120Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc.20071,405—
+3K071497Atlas Spine Vertebral Body ReplacementAtlas Spine, Inc.20070—
+3K063399Aleutian Spacer SystemK2m, Inc.2007663—
+3K060350Construx PL/TL Peek Partial VBR SystemBlackstone Medical, Inc.2006754—
+4K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+4K260840BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20261—
+4K253213SAGI Cervical Cage SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+4K253260ORIO-3D Cage SystemSpineCraft20260—
+4K252219Cervical Interbody and VBR Fusion SystemSync Surgical20260—
+4K252711Advantage-C™ Ti3D Cervical Interbody Fusion DeviceIntelivation Technologies20260—
+4K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+4K243074Spectrum Spine Lumbar Cage SystemSpectrum Spine, Inc.20252—
+4K242483Genesys Spine AIS-C II Cervical Interbody Fusion SystemGenesys Spine20250—
+4K2316554CIS® Chiron Spinal Fixation SystemSolco Biomedical Co., Ltd.20240—
+4K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+4K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+4K241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc.20241—
+4K233807LumiVy™ Lumbar IBF SystemVy Spine, LLC20241—
+4K241605Adaptix™ PEEK Interbody System with Nanotechnology; Capstone Control™ PEEK Spinal System…Nanovis, LLC20240—
+4K241846E3D™-C Interbody SystemEvolution Spine20246—
+4K241019aprevo® TLIF-C Articulating SystemCarlsmed20244—
+4K240368E3D™-A Interbody SystemEvolution Spine20247—