510(k) Report

Devices descending from K113559

383 later devices reach LDR Spine Cervical Interbody Fusion Systme-Roi-C Lordotic Implants through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K212612Omnia Medical TiBrid-SCOmnia Medical, LLC20220—
+3K212527Cervical Spine Truss System Plating Solution (CSTS-PS)4Web Medical, Inc.20220—
+3K212904SeaSpine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202115—
+3K213359SeaSpine WaveForm, C Interbody SystemSeaSpine Orthopedics Corporation20217—
+3K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210—
+3K211413BEE PLIF CageNGMedical GmbH20211—
+3K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+3K210382Blustone Synergy Diamond SA Cervical SystemBlustone Synergy, LLC20210—
+3K203444BEE HA CageNGMedical GmbH20211—
+3K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc.202135—
+3K200429BEE CagesNGMedical GmbH202111—
+3K203683CarboClear Lumbar Cage SystemCarbofix Orthpedics, Ltd.20211—
+3K203076Mecta-C Stand Alone ExtensionMedacta International S.A.20200—
+3K202065DOLOMITE Anterior Cervical Stabilization SystemAstura Medical, LLC20203—
+3K193000Hexanium® ACIFSpinevision, S.A.S.202014—
+3K201453Fortilink Cages with TiPlus TechnologyParadigm Spine GmbH20204—
+3K200685RIGEL 3DR Anterior Cervical Interbody Fusion SystemMiRus, LLC20200—
+3K193153SPIRA-C Integrated Fixation SystemCamber Spine Technologies20202—
+3K200312Tryptik TiSpineart20202—
+3K200543NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) SystemNexxt Spine, LLC202072—
+3K192897icotec Cervical CageIcotec AG20201—
+3K193378CarboClear Lumbar Cage SystemCarboFix Orthopedics, Ltd.20202—
+3K182987Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20199—
+3K191477AEON-C Stand Alone SystemHuvexel Co., Ltd.201910—
+3K1803473d CageFims Co., Ltd.20190—
+3K191243HEDRON Cervical SpacersGlobus Medical, Inc.201936—
+3K192018Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic…Titan Spine, Inc.20191024
+3K190885Elevation Spine Saber-C SystemElevation Spine201925—
+3K183249Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved…Stryker Spine20196—
+3K190655SeaSpine® Shoreline™ ACS- Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation201974—
+3K183092Kuros TLIF CageKuros Biosciences B.V20190—
+3K183083Shoreline Cervical Interbody RT SystemSeaSpine Orthopedics Corporation201960—
+3K183447EIT Cellular Titanium Lumbar Cage - T/PLIFEit Emerging Implant Technologies GmbH2019131—
+3K181347Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC201824—
+3K172484A-CIFT SoloFuseSpinefrontier, Inc.201871
+3K173347STALIF C FLX, STALIF M FLX, STALIF L FLX and STALIF Lateral-Oblique FLX, ACTILIF C FLX…Centinel Spine, Inc.201812—
+3K173535Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TAS Hyperlordotic Interbody…Titan Spine, LLC20181052
+3K172888EIT Cellular Titanium® Cervical Cages, EIT Cellular Titanium® PLIF Cages, EIT Cellular…Eit Emerging Implant Technologies GmbH2017159—
+3K173175Paramount Anterior Cervical Cage SystemSpine Wave, Inc.20170—
+3K151677LnK Cervical Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20158—
+4K261408SABER-XA SystemElevation Spine20260—
+4K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—
+4K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+4K261279DeltaNEC Interbody SystemNexus Spine20260—
+4K253894BMD Titanium Spinal Fusion SystemGlobal Biomedica s.r.o.20260—
+4K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+4K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+4K260660SABER-C SystemElevation Spine20261—
+4K253260ORIO-3D Cage SystemSpineCraft20260—
+4K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine20260—
+4K253559Ventana™ A Anterior Lumbar Interbody SystemSpinal Elements, Inc.20260—
+4K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc.20250—
+4K250764SpineLinc Anterior Cervical Implant SystemLincotek Medical20250—
+4K250769Dakota LP SystemPrecision Spine, Inc.20250—
+4K250560BEE HANGMedical GmbH20250—
+4K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+4K253377Expandable Titanium PLIF/TLIF SystemSpectrum Spine, Inc.20250—
+4K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting20250—
+4K250540SABER-C SystemElevation Spine20252—
+4K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—
+4K251117Cervical Spine Truss System (CSTS)4Web Medical20250—
+4K242928Tesera-k SC SystemKyocera Medical Technologies, Inc.20250—
+4K243074Spectrum Spine Lumbar Cage SystemSpectrum Spine, Inc.20252—
+4K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+4K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+4K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+4K241738PYXIS 3D Titanium Cervical Cage systemGS Medical Co., Ltd.20241—
+4K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+4K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody…Orthofix Medical, Inc.20242—
+4K241466Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System…SeaSpine Orthopedics Corporation20243—
+4K233966Anterior Spine Truss System-Stand Alone (ASTS-SA)4Web Medical, Inc.20241—
+4K233375Tranquil-L Interbody SystemNexus Spine, LLC20240—
+4K240416Tranquil-C Interbody SystemNexus Spine, LLC20243—
+4K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+4K233414Shoreline ACS Interbody System; Shoreline RT Interbody SystemSeaSpine Orthopedics Corporation20238—
+4K231147Hammerdesis™ Interphalangeal Fusion SystemIntelivation20230—
+4K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+4K222874CarboClear Cervical Cage System, CarboClear Cervical VBR SystemCarbofix Orthpedics, Ltd.20230—
+4K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+4K231252Ventana™ L Spinal SystemSpinal Elements, Inc.20231—
+4K222833Ventana™ C Spinal SystemSpinal Elements, Inc.20234—
+4K222004INTEGRATE -C Interbody Fusion SystemHappe Spine20236—
+4K223868PYXIS 3D Titanium Cage SystemGS Medical Co., Ltd.20232—
+4K230583Tryptik TiSpineart SA20231—
+4K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+4K220296Manta Ray TDF SpacerSeaSpine Orthopedics Corporation20231—
+4K223140AEON-C™ Stand Alone SystemDio Medical, Inc.20222—
+4K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—
+4K221578Hexanium ACIFSpinevision, S.A.S.20224—
+4K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+4K221447Southern Anterior Screw Fixated Cage (SASCA)Southern Medical (Pty), Ltd.20220—
+4K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+4K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+4K213118Dakota ALIF SystemPrecision Spine, Inc.20220—
+4K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20227—
+4K220096Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20220—
+4K211474Kleiner KG2 SystemBAAT Medical Products B.V.20210—
+4K210470C-CURVE Interbody Fusion DeviceMedicrea International SA20210—
+4K211903Shoreline Threaded TruProfile® PlateSeaSpine Orthopedics Corporation20217—
+4K210497SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202139—