510(k) Report

Devices descending from K080728

903 later devices reach LDR Spine Roi-C Implant through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K083857LDR Spine Roi-C ImplantLdr Spine USA2009902—
+2K091088LDR Spine Cervical Interbody Fusion SystemLdr Spine USA2009901—
+3K241396uCerv Flux™-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA, Inc.20240—
+3K233191TotalTi ACDF by SAGICOSpinal Analytics & Geometrical Implant Co, LLC20230—
+3K221138Titus Titanium Cervical by SAGICOSagico VA USA, LLC20231—
+3K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+3K200549Lucero Medical Cervical Cage SystemLucero Medical, LLC20200—
+3K202065DOLOMITE Anterior Cervical Stabilization SystemAstura Medical, LLC20203—
+3K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine20207—
+3K191822Nano FortiCore, FortiCoreNanovis, LLC20192—
+3K191537eCarbon IBDsBack 2 Basics Direct, LLC20193—
+3K191354Ti3Z Cervical Interbody SystemZavation Medical Products, LLC201913—
+3K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC201993—
+3K182477Cervical SpacerAdditive Implants, LLC201915—
+3K180056Genesys Spine AIS-C Cervical Anchored Interbody SystemGenesys Spine201818—
+3K173148ACIFColigne AG20171—
+3K170844Gemini-C Hybrid Cervical Interbody SystemOsseus Fusion Systems, LLC20170—
+3K170297Tranquil Interbody SystemNexus Spine, LLC201715—
+3K162206Zavation IBFZavation, LLC201724—
+3K152099Genesys Spine Apache® Anchored Cervical Interbody Fusion SystemGenesys Spine201619—
+3K160154ALTA Anterior Cervical Interbody SpacerAstura Medical201663—
+3K152532AERO -C Cervical Cage SystemStryker Spine2015145—
+3K143572Intersomatic Cervical Device - DICOM PEEK, Intersomatic Intervertebral Space Maintenance…Osteomed Implantes, Ltda20150—
+3K142940Endoskeleton TCS SystemTitan Spine, LLC20151112
+3K141129Exactech Cervical Spacer SystemExactech, Inc.20148—
+3K141005Z-Link CervicalZavation, LLC20144—
+3K133815Intess Cervical Cage SystemKalitec Direct, LLC20144—
+3K132999Cervical Stand Alone SystemOrthofix, Inc.2014281—
+3K131880Spinefrontier a-Cift Solofuse Cervical Intervertebral Fusion Device SystemSpinefrontier, Inc.201427—
+3K132029Vault-C Intervertebral Body Fusion DeviceSpinal USA2013108—
+3K132718Integrity Spine Core SystemIntegrity Spine20131—
+3K122588Vusion CS PlusOrtho Development Corp.2013206—
+3K123206Maxim Surgical X-Treme Interbody Fusion SystemMaxim Surgical2013454—
+3K123388K7C SpacerK7, LLC20130—
+3K122008Incite Anchored Cervical Interbody (Aci) Fusion DeviceIncite Innovation, LLC201210—
+3K121103LDR Spine Usa Spine Tune, TL Spinal System, LDR Spine Usa Easyspine, Posterior Spinal…Ldr Spine USA, Inc.201216—
+3K121176STGCCardinal Spine, LLC201259—
+3K121569Matisse Anterior Cervical Interbody Fusion Cage SystemAccel Spine20123—
+3K120840Lexus Cervical Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd.201214—
+3K120517Depuy Pulse Cervical Cage SystemMedos International SARL20123—
+3K120576Zavation Ibf SystemZavation, LLC201232—
+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—
+3K110659Medical Concepts Interbody Fusion SystemMedical Concepts, Inc.20111—
+3K111484DiscoveryIntuitive Spine, LLC20111—
+3K102606Avs Anchor-C Cervical Cage SystemStryker Spine20113841
+3K100698STCCCardinal Spine, LLC2011346—
+3K103660Lanx Cervical Intervertebral Body Fusion SystemLanx, Inc.201141—
+3K101363VU Cpod Intervertebral Bodu Fusion DeviceMusculoskeletal Clinical Regulatory Advisers201078—
+3K103034Genesys Spine Interbody Fusion SystemGenesys Spine20101371
+3K100214Cornerstone PSR Cervical Interbody Fusion DeviceMedtronic Sofamor Danek2010389—
+4K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+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—
+4K252711Advantage-C™ Ti3D Cervical Interbody Fusion DeviceIntelivation Technologies20260—
+4K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+4K241605Adaptix™ PEEK Interbody System with Nanotechnology; Capstone Control™ PEEK Spinal System…Nanovis, LLC20240—
+4K240715Idys® C ZP 3DTiClariance20240—
+4K233375Tranquil-L Interbody SystemNexus Spine, LLC20240—
+4K240416Tranquil-C Interbody SystemNexus Spine, LLC20243—
+4K233594Genesys Spine 3DP AIS-C II Cervical Interbody SystemGenesys Spine20232—
+4K230478Acro Composites Interbody SystemAcro Composites, LLC20230—
+4K222874CarboClear Cervical Cage System, CarboClear Cervical VBR SystemCarbofix Orthpedics, Ltd.20230—
+4K220513NITRO Interbody Fusion Cage System FamilyCtl Medical Corporation20230—
+4K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+4K223043The Integrity Spine Core SystemIntegrity Spine20230—
+4K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+4K223146EVOLUTION SPINE Interbody SystemEvolution Spine20239—
+4K220296Manta Ray TDF SpacerSeaSpine Orthopedics Corporation20231—
+4K222806Kodiak C Spinal Implant SystemMet One Technologies, LLC20221—
+4K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+4K212853Cervical Stand-Alone SystemEminent Spine, LLC202118—
+4K212562Idys-C ZP 3DTiClariance, SA20211—
+4K211501Advantage-C PEEK Cervical lnterbody Fusion DeviceLntelivation, LLC20211—
+4K210521DEXA-C Cervical Interbody SystemAurora Spine, Inc.20210—
+4K210382Blustone Synergy Diamond SA Cervical SystemBlustone Synergy, LLC20210—
+4K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+4K203683CarboClear Lumbar Cage SystemCarbofix Orthpedics, Ltd.20211—
+4K203129NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) SystemPrecision Spine, Inc.20210—
+4K193000Hexanium® ACIFSpinevision, S.A.S.202014—
+4K202305Zavation IBF SystemZavation Medical Products, LLC20209—
+4K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC202025—
+4K193153SPIRA-C Integrated Fixation SystemCamber Spine Technologies20202—
+4K200543NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) SystemNexxt Spine, LLC202072—
+4K192906Mecta-C Stand AloneMedacta International S.A.20201—
+4K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+4K193359SureMAX Family of Cervical SpacersAdditive Implants, Inc.202014—
+4K182987Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20199—
+4K190426ALTA Anterior Cervical Corpectomy SystemAstura Medical, LLC20193—
+4K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer…Choice Spine, LLC20194—
+4K190870Cervical Spinal Truss System-Stand Alone (CSTS-SA)4Web, Inc.201910—
+4K191565Endoskeleton TCS Interbody Fusion DeviceTitan Spine, Inc.201901
+4K183083Shoreline Cervical Interbody RT SystemSeaSpine Orthopedics Corporation201960—
+4K182210TiWAVE-L Porous Titanium Lumbar CageKalitec Medical, LLC20193—
+4K181621Stable-C Interbody SystemNexus Spine, LLC20187—
+4K181702Tranquil-L Interbody SystemNexus Spine, LLC20188—
+4K181229TirboLOX-C Cervical IBFDCaptiva Spine, Inc.20180—