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
+1K181621Stable-C Interbody SystemNexus Spine, LLC20187—
+1K181229TirboLOX-C Cervical IBFDCaptiva Spine, Inc.20180—
+1K181295Genesys Spine AIS-C Cervical Stand-Alone SystemGenesys Spine201817—
+1K180056Genesys Spine AIS-C Cervical Anchored Interbody SystemGenesys Spine201818—
+1K172320Neurostructures Cavetto® Cervical Cage SystemNeurostructures, Inc.20183—
+1K161710Sagico Ibf System – Aria Lumbar, Sagico Ibf System – Arion CervicalSpinal Analytics & Geometrical Impant Co, LLC201741—
+1K163474CAVUX CervicalCage-L SA SystemProvidence Medical Technology, Inc.20170—
+1K152099Genesys Spine Apache® Anchored Cervical Interbody Fusion SystemGenesys Spine201619—
+1K151939COALITION SpacersGlobus Medical, Inc.2016152—
+1K152793Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.201629—
+1K151934ROI-C Titanium-Coated Implant SystemLdr Spine USA20159—
+1K150765LDR Spine ROI-C Cervical Cage SystemLdr Spine USA201559—
+1K142940Endoskeleton TCS SystemTitan Spine, LLC20151112
+1K141129Exactech Cervical Spacer SystemExactech, Inc.20148—
+1K132582Exactech Acapella One Cervical Spacer SystemExactech, Inc.2014471
+1K131880Spinefrontier a-Cift Solofuse Cervical Intervertebral Fusion Device SystemSpinefrontier, Inc.201427—
+1K132029Vault-C Intervertebral Body Fusion DeviceSpinal USA2013108—
+1K122588Vusion CS PlusOrtho Development Corp.2013206—
+1K121151Pro-Link Cervical Spacer SystemLife Spine, Inc.2012116—
+1K121569Matisse Anterior Cervical Interbody Fusion Cage SystemAccel Spine20123—
+1K120840Lexus Cervical Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd.201214—
+2K260840BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20261—
+2K252774Uni-C Cervical Cage SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+2K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+2K242483Genesys Spine AIS-C II Cervical Interbody Fusion SystemGenesys Spine20250—
+2K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+2K241846E3D™-C Interbody SystemEvolution Spine20246—
+2K240715Idys® C ZP 3DTiClariance20240—
+2K233191TotalTi ACDF by SAGICOSpinal Analytics & Geometrical Implant Co, LLC20230—
+2K231704Pro-Link® & Pro-Link® Ti Barbs Cervical Spacer SystemLife Spine, Inc.20230—
+2K231763Stable-C Interbody SystemNexus Spine, LLC20236—
+2K230607SPICCA Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+2K221138Titus Titanium Cervical by SAGICOSagico VA USA, LLC20231—
+2K223143SAGICO Spinal SystemSagico VA USA, LLC20230—
+2K220513NITRO Interbody Fusion Cage System FamilyCtl Medical Corporation20230—
+2K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+2K212853Cervical Stand-Alone SystemEminent Spine, LLC202118—
+2K212562Idys-C ZP 3DTiClariance, SA20211—
+2K211111SureMAX-SA Cervical Standalone SystemAdditive Implants, Inc.20218—
+2K203311ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20213—
+2K203129NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) SystemPrecision Spine, Inc.20210—
+2K201073Seaspine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202017—
+2K201769Cavetto [MAX] Cervical Cage SystemNeurostructures, Inc.20200—
+2K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC202025—
+2K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine20207—
+2K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer…Choice Spine, LLC20194—
+2K190870Cervical Spinal Truss System-Stand Alone (CSTS-SA)4Web, Inc.201910—
+2K191565Endoskeleton TCS Interbody Fusion DeviceTitan Spine, Inc.201901
+2K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC201993—
+2K181096Avenue P Cage SystemZimmer Biomet Spine, Inc.20190—
+2K180909REVEL SpacersGlobus Medical, Inc.201837—
+2K181590Neurostructures Cavetto® [MAX] Cervical Cage SystemNeurostructures, Inc.20180—
+2K172788MONET™ Anterior Cervical Interbody Fusion Cage SystemCtl Medical Corporation20181—
+2K172480icotec Interbody Cage SystemIcotec AG20185—
+2K180642Pro-Link® Ti Stand-Alone Cervical Spacer SystemLife Spine, Inc.20182—
+2K172212MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEK™Ctl Medical Corporation20181—
+2K171848FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO…Globus Medical, Inc.201755—
+2K173115COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and…Globus Medical, Inc.201783—
+2K171489Acapella Cervical Spacer SystemChoicespine, LP201739—
+2K170503EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular…Eit Emerging Implant Technologies GmbH20171992
+2K170830Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20175—
+2K170569SeaSpine Shoreline ACS - Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation201782—
+2K162760Spine Wave Anterior Cervical Spine SystemSpine Wave, Inc.20171—
+2K161081SeaSpine Shoreline ACS - Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation201683—
+2K160066Pro-Link® Stand-Alone Cervical Spacer SystemLife Spine, Inc.20163—
+2K153122Endoskeleton (r) TCS SystemTitan Spine, LLC20151061
+2K151596Endoskeleton TCS Interbody Fusion DeviceTitan Spine, LLC20151101
+2K151198A-CIFT SoloFuseSpinefrontier, Inc.20158—
+2K150130Ascendant TM Cervical Spacer SystemExactech, Inc.20157—
+2K143360LnK Cervical Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20159—
+3K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+3K262489BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20260—
+3K2530413d Cage CervicalFims Co., Ltd.20260—
+3K262094E3D™-C Interbody SystemEvolution Spine20260—
+3K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+3K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+3K261067BEE PLIF CageNGMedical GmbH20260—
+3K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+3K260038E3D™-C Interbody SystemEvolution Spine20261—
+3K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+3K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+3K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc.20251—
+3K241467Stable-C Interbody SystemNexus Spine, LLC20242—
+3K240838Spectrum Spine Cervical Cage SystemSpectrum Spine, Inc.20244—
+3K240699SCARLET® AC-TiSpineart SA20240—
+3K232792icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec…Icotec AG20240—
+3K233594Genesys Spine 3DP AIS-C II Cervical Interbody SystemGenesys Spine20232—
+3K232348RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion SystemMiRus, LLC20231—
+3K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+3K231739Cervical Spine Truss System (CSTS)4Web Medical, Inc.20232—
+3K232530Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemNexus Spine, LLC20235—
+3K223869ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20232—
+3K230608SPICCA Stand-Alone Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+3K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+3K230329F3D Interbody SystemCorelink, LLC20230—
+3K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+3K223362Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device4Web Medical, Inc.20233—
+3K223105Tesera-K SC SystemKyocera Medical Technologies, Inc.20225—
+3K223190Hive™ Standalone Cervical SystemNanoHive Medical, LLC20225—
+3K222903Tailored-H Cervical Stand Alone SystemBespoke Technologies, LLC20220—