510(k) Report

Devices descending from K043479

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+2K120840Lexus Cervical Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd.201214—
+2K120517Depuy Pulse Cervical Cage SystemMedos International SARL20123—
+2K120656Everest Spinal SystemK2m, Inc.201243—
+2K120576Zavation Ibf SystemZavation, LLC201232—
+2K111820Synster Cervical Cage, Alif Cage, Plif Cage, Ptlif Cage, Tlif CageBm Korea Co., Ltd.201220—
+2K120024Mectalif TransforaminalMedacta International S.A.201223—
+2K113518Arena-C Cervical Intervertebral Body Fusion SystemSpinefrontier, Inc.2012193—
+2K113138Aleutian SystemK2m, Inc.2012549—
+2K113559LDR Spine Cervical Interbody Fusion Systme-Roi-C Lordotic ImplantsLdr Spine USA, Inc.2011383—
+2K112664Zavation Ibf SystemsZavation, LLC201137—
+2K111123Varilift Cervical Interbody Fusion SystemWenzel Spine2011196—
+2K110442Nanovis Intervertebral Body Fusion SystemNanovis, LLC201110—
+2K111512Bonebac T-Plif Intervertebral Body Fusion Device SystemThompson Mis, Inc.2011762—
+2K111484DiscoveryIntuitive Spine, LLC20111—
+2K102606Avs Anchor-C Cervical Cage SystemStryker Spine20113841
+2K110177Helena SystemRoyal Oak Medical Devices20110—
+2K102402Solus Anterior Lumbar Interbody Fusion (Alif) Spinal Spacer SystemAlphatec Spine, Inc.20111121
+2K100698STCCCardinal Spine, LLC2011346—
+2K103660Lanx Cervical Intervertebral Body Fusion SystemLanx, Inc.201141—
+2K101363VU Cpod Intervertebral Bodu Fusion DeviceMusculoskeletal Clinical Regulatory Advisers201078—
+2K101812Construx Mini Peek Spacer SystemOrthofix, Inc.2010291—
+2K100214Cornerstone PSR Cervical Interbody Fusion DeviceMedtronic Sofamor Danek2010389—
+3K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+3K260840BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20261—
+3K253213SAGI Cervical Cage SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+3K253260ORIO-3D Cage SystemSpineCraft20260—
+3K252219Cervical Interbody and VBR Fusion SystemSync Surgical20260—
+3K252711Advantage-C™ Ti3D Cervical Interbody Fusion DeviceIntelivation Technologies20260—
+3K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+3K243074Spectrum Spine Lumbar Cage SystemSpectrum Spine, Inc.20252—
+3K242483Genesys Spine AIS-C II Cervical Interbody Fusion SystemGenesys Spine20250—
+3K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+3K241605Adaptix™ PEEK Interbody System with Nanotechnology; Capstone Control™ PEEK Spinal System…Nanovis, LLC20240—
+3K241846E3D™-C Interbody SystemEvolution Spine20246—
+3K240368E3D™-A Interbody SystemEvolution Spine20247—
+3K240715Idys® C ZP 3DTiClariance20240—
+3K233375Tranquil-L Interbody SystemNexus Spine, LLC20240—
+3K240416Tranquil-C Interbody SystemNexus Spine, LLC20243—
+3K232432E3D™-A Interbody SystemEvolution Spine20248—
+3K231715MONDRIAN™ Anterior Lumbar Plate SystemCtl Medical Corporation20240—
+3K233594Genesys Spine 3DP AIS-C II Cervical Interbody SystemGenesys Spine20232—
+3K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+3K231704Pro-Link® & Pro-Link® Ti Barbs Cervical Spacer SystemLife Spine, Inc.20230—
+3K231763Stable-C Interbody SystemNexus Spine, LLC20236—
+3K230607SPICCA Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+3K222874CarboClear Cervical Cage System, CarboClear Cervical VBR SystemCarbofix Orthpedics, Ltd.20230—
+3K220513NITRO Interbody Fusion Cage System FamilyCtl Medical Corporation20230—
+3K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+3K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+3K220296Manta Ray TDF SpacerSeaSpine Orthopedics Corporation20231—
+3K223731NuVasive Modulus-C Interbody SystemNuvasive, Inc.202311—
+3K222806Kodiak C Spinal Implant SystemMet One Technologies, LLC20221—
+3K220096Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20220—
+3K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+3K212853Cervical Stand-Alone SystemEminent Spine, LLC202118—
+3K212389Advantage Lumbar System - ALIF, PLIF, DLIF, TLIFIntelivation, LLC20210—
+3K212562Idys-C ZP 3DTiClariance, SA20211—
+3K211501Advantage-C PEEK Cervical lnterbody Fusion DeviceLntelivation, LLC20211—
+3K210521DEXA-C Cervical Interbody SystemAurora Spine, Inc.20210—
+3K210382Blustone Synergy Diamond SA Cervical SystemBlustone Synergy, LLC20210—
+3K203520Blustone Synergy Interbody Fusion SystemBlustone Synergy, LLC20210—
+3K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+3K203129NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) SystemPrecision Spine, Inc.20210—
+3K201643ChoiceSpine Tiger Shark Cervical Spacer SystemChoice Spine, LLC20204—
+3K193000Hexanium® ACIFSpinevision, S.A.S.202014—
+3K202305Zavation IBF SystemZavation Medical Products, LLC20209—
+3K201769Cavetto [MAX] Cervical Cage SystemNeurostructures, Inc.20200—
+3K192863MONDRIAN Lumbar Interbody Fusion Cage SystemCtl Medical Corporation20203—
+3K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC202025—
+3K193153SPIRA-C Integrated Fixation SystemCamber Spine Technologies20202—
+3K200543NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) SystemNexxt Spine, LLC202072—
+3K192906Mecta-C Stand AloneMedacta International S.A.20201—
+3K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+3K193645nva, nvp, and nvtNvision Biomedical Technologies, Inc.20203—
+3K193359SureMAX Family of Cervical SpacersAdditive Implants, Inc.202014—
+3K1803473d CageFims Co., Ltd.20190—
+3K190426ALTA Anterior Cervical Corpectomy SystemAstura Medical, LLC20193—
+3K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer…Choice Spine, LLC20194—
+3K190870Cervical Spinal Truss System-Stand Alone (CSTS-SA)4Web, Inc.201910—
+3K191565Endoskeleton TCS Interbody Fusion DeviceTitan Spine, Inc.201901
+3K190618RIGEL PEEK Anterior Cervical Interbody Fusion SystemMiRus, LLC20191—
+3K190380nvcNvision Biomedical Technologies, Inc.20193—
+3K183083Shoreline Cervical Interbody RT SystemSeaSpine Orthopedics Corporation201960—
+3K182210TiWAVE-L Porous Titanium Lumbar CageKalitec Medical, LLC20193—
+3K183239CoreLink F3D™ Lateral SystemCorelink, LLC20188—
+3K182746ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc.2018110—
+3K181590Neurostructures Cavetto® [MAX] Cervical Cage SystemNeurostructures, Inc.20180—
+3K181621Stable-C Interbody SystemNexus Spine, LLC20187—
+3K181397DualXInnovasive, Inc.201815—
+3K181702Tranquil-L Interbody SystemNexus Spine, LLC20188—
+3K181229TirboLOX-C Cervical IBFDCaptiva Spine, Inc.20180—
+3K181337Sypher Spacer SystemBiogennix, LLC20180—
+3K181483Tranquil Interbody SystemNexus Spine, LLC20186—
+3K180814CoreLink® M3™ Stand-Alone Anterior Lumbar SystemCorelink, LLC201818—
+3K180076Ti 3Z Interbody SystemZavation Medical Products, LLC20184—
+3K180556Corelink Foundation 3D Anterior Lumbar SystemCorelink, LLC20185—
+3K181030Rubicon Lumbar Interbody Fusion SystemRubicon Spine, LLC20180—
+3K181246Zavation IBF SystemZavation Medical Products, LLC201822—
+3K172788MONET™ Anterior Cervical Interbody Fusion Cage SystemCtl Medical Corporation20181—
+3K180674EVOL® ha-C Cervical Interbody Fusion SystemCutting Edge Spine, LLC20183—