510(k) Report

Devices descending from K083857

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K091088LDR Spine Cervical Interbody Fusion SystemLdr Spine USA2009901—
+2K241396uCerv Flux™-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA, Inc.20240—
+2K233191TotalTi ACDF by SAGICOSpinal Analytics & Geometrical Implant Co, LLC20230—
+2K221138Titus Titanium Cervical by SAGICOSagico VA USA, LLC20231—
+2K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+2K200549Lucero Medical Cervical Cage SystemLucero Medical, LLC20200—
+2K202065DOLOMITE Anterior Cervical Stabilization SystemAstura Medical, LLC20203—
+2K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine20207—
+2K191822Nano FortiCore, FortiCoreNanovis, LLC20192—
+2K191537eCarbon IBDsBack 2 Basics Direct, LLC20193—
+2K191354Ti3Z Cervical Interbody SystemZavation Medical Products, LLC201913—
+2K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC201993—
+2K182477Cervical SpacerAdditive Implants, LLC201915—
+2K180056Genesys Spine AIS-C Cervical Anchored Interbody SystemGenesys Spine201818—
+2K173148ACIFColigne AG20171—
+2K170844Gemini-C Hybrid Cervical Interbody SystemOsseus Fusion Systems, LLC20170—
+2K170297Tranquil Interbody SystemNexus Spine, LLC201715—
+2K162206Zavation IBFZavation, LLC201724—
+2K152099Genesys Spine Apache® Anchored Cervical Interbody Fusion SystemGenesys Spine201619—
+2K160154ALTA Anterior Cervical Interbody SpacerAstura Medical201663—
+2K152532AERO -C Cervical Cage SystemStryker Spine2015145—
+2K143572Intersomatic Cervical Device - DICOM PEEK, Intersomatic Intervertebral Space Maintenance…Osteomed Implantes, Ltda20150—
+2K142940Endoskeleton TCS SystemTitan Spine, LLC20151112
+2K141129Exactech Cervical Spacer SystemExactech, Inc.20148—
+2K141005Z-Link CervicalZavation, LLC20144—
+2K133815Intess Cervical Cage SystemKalitec Direct, LLC20144—
+2K132999Cervical Stand Alone SystemOrthofix, Inc.2014281—
+2K131880Spinefrontier a-Cift Solofuse Cervical Intervertebral Fusion Device SystemSpinefrontier, Inc.201427—
+2K132029Vault-C Intervertebral Body Fusion DeviceSpinal USA2013108—
+2K132718Integrity Spine Core SystemIntegrity Spine20131—
+2K122588Vusion CS PlusOrtho Development Corp.2013206—
+2K123206Maxim Surgical X-Treme Interbody Fusion SystemMaxim Surgical2013454—
+2K123388K7C SpacerK7, LLC20130—
+2K122008Incite Anchored Cervical Interbody (Aci) Fusion DeviceIncite Innovation, LLC201210—
+2K121103LDR Spine Usa Spine Tune, TL Spinal System, LDR Spine Usa Easyspine, Posterior Spinal…Ldr Spine USA, Inc.201216—
+2K121176STGCCardinal Spine, LLC201259—
+2K121569Matisse Anterior Cervical Interbody Fusion Cage SystemAccel Spine20123—
+2K120840Lexus Cervical Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd.201214—
+2K120517Depuy Pulse Cervical Cage SystemMedos International SARL20123—
+2K120576Zavation Ibf SystemZavation, LLC201232—
+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—
+2K110659Medical Concepts Interbody Fusion SystemMedical Concepts, Inc.20111—
+2K111484DiscoveryIntuitive Spine, LLC20111—
+2K102606Avs Anchor-C Cervical Cage SystemStryker Spine20113841
+2K100698STCCCardinal Spine, LLC2011346—
+2K103660Lanx Cervical Intervertebral Body Fusion SystemLanx, Inc.201141—
+2K101363VU Cpod Intervertebral Bodu Fusion DeviceMusculoskeletal Clinical Regulatory Advisers201078—
+2K103034Genesys Spine Interbody Fusion SystemGenesys Spine20101371
+2K100214Cornerstone PSR Cervical Interbody Fusion DeviceMedtronic Sofamor Danek2010389—
+3K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+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—
+3K252711Advantage-C™ Ti3D Cervical Interbody Fusion DeviceIntelivation Technologies20260—
+3K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+3K241605Adaptix™ PEEK Interbody System with Nanotechnology; Capstone Control™ PEEK Spinal System…Nanovis, LLC20240—
+3K240715Idys® C ZP 3DTiClariance20240—
+3K233375Tranquil-L Interbody SystemNexus Spine, LLC20240—
+3K240416Tranquil-C Interbody SystemNexus Spine, LLC20243—
+3K233594Genesys Spine 3DP AIS-C II Cervical Interbody SystemGenesys Spine20232—
+3K230478Acro Composites Interbody SystemAcro Composites, LLC20230—
+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—
+3K223043The Integrity Spine Core SystemIntegrity Spine20230—
+3K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+3K223146EVOLUTION SPINE Interbody SystemEvolution Spine20239—
+3K220296Manta Ray TDF SpacerSeaSpine Orthopedics Corporation20231—
+3K222806Kodiak C Spinal Implant SystemMet One Technologies, LLC20221—
+3K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+3K212853Cervical Stand-Alone SystemEminent Spine, LLC202118—
+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—
+3K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+3K203683CarboClear Lumbar Cage SystemCarbofix Orthpedics, Ltd.20211—
+3K203129NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) SystemPrecision Spine, Inc.20210—
+3K193000Hexanium® ACIFSpinevision, S.A.S.202014—
+3K202305Zavation IBF SystemZavation Medical Products, LLC20209—
+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—
+3K193359SureMAX Family of Cervical SpacersAdditive Implants, Inc.202014—
+3K182987Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20199—
+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
+3K183083Shoreline Cervical Interbody RT SystemSeaSpine Orthopedics Corporation201960—
+3K182210TiWAVE-L Porous Titanium Lumbar CageKalitec Medical, LLC20193—
+3K181621Stable-C Interbody SystemNexus Spine, LLC20187—
+3K181702Tranquil-L Interbody SystemNexus Spine, LLC20188—
+3K181229TirboLOX-C Cervical IBFDCaptiva Spine, Inc.20180—
+3K181295Genesys Spine AIS-C Cervical Stand-Alone SystemGenesys Spine201817—