510(k) Report

Devices descending from K142264

532 later devices reach Valeo C Spacer System, Valeo II C IBF Device through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K242303MOD-COrthomod, LLC20260—
+1K173453Valeo® C+CSC with Lumen Interbody Fusion DeviceAmedica Corp.20180—
+1K160528ANATOMIC PEEK PTC Cervical Fusion SystemMedtronic Sofamor Danek USA, Inc.201623—
+1K143518Valeo Spacer System and Valeo II Interbody Fusion Device SystemAmedica Corp.20155—
+1K150765LDR Spine ROI-C Cervical Cage SystemLdr Spine USA201559—
+1K150619CONSTRUX Mini PEEK Spacer System, CONSTRUX Mini PEEK Ti Spacer SystemOrthofix, Inc.2015107—
+1K151322Amendia Interbody Fusion DevicesAmendia, Inc.20152261
+1K150362NuVasive CoRoent Small Interbody SystemNu Vasive, Incorporated2015441—
+2K252774Uni-C Cervical Cage SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+2K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+2K220513NITRO Interbody Fusion Cage System FamilyCtl Medical Corporation20230—
+2K211845Deploy Expandable Interbody SystemSouthern Spine, LLC20210—
+2K202949CONSTRUX Mini PEEK Spacer SystemOrthofix, Inc.20206—
+2K192863MONDRIAN Lumbar Interbody Fusion Cage SystemCtl Medical Corporation20203—
+2K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+2K182920MiRus™ Lumbar Interbody Fusion System consisting of CALLISTO™ PEEK Posterior Lumbar…MiRus, LLC20199—
+2K181621Stable-C Interbody SystemNexus Spine, LLC20187—
+2K181229TirboLOX-C Cervical IBFDCaptiva Spine, Inc.20180—
+2K181435ATEC Cervical Spacer SystemAlphatec Spine, Inc.2018100—
+2K180674EVOL® ha-C Cervical Interbody Fusion SystemCutting Edge Spine, LLC20183—
+2K173722PATRIOT COLONIAL Spacer, SUSTAIN SpacerGlobus Medical, Inc.201894—
+2K172320Neurostructures Cavetto® Cervical Cage SystemNeurostructures, Inc.20183—
+2K172437CONSTRUX® Mini PTC Spacer System, FORZA® PTC Spacer System, PILLAR® SA PTC Spacer SystemOrthofix, Inc.2017143
+2K171075Calix-C Cervical Interbody SpacerX-Spine Systems, Inc.201715—
+2K170550Coveris Cervical Cage SystemCamber Spine Technologies20171—
+2K171046SeaSpine Cambria SystemSeaSpine Orthopedics Corporation201762—
+2K170844Gemini-C Hybrid Cervical Interbody SystemOsseus Fusion Systems, LLC20170—
+2K161710Sagico Ibf System – Aria Lumbar, Sagico Ibf System – Arion CervicalSpinal Analytics & Geometrical Impant Co, LLC201741—
+2K162496Foundation 3D InterbodyCorelink, LLC201782—
+2K163491NuVasive CoRoent Small Interbody SystemNu Vasive, Incorporated2017289—
+2K163474CAVUX CervicalCage-L SA SystemProvidence Medical Technology, Inc.20170—
+2K162760Spine Wave Anterior Cervical Spine SystemSpine Wave, Inc.20171—
+2K162587Roccia® AcifSilony Medical GmbH20171—
+2K160924Amendia Interbody Fusion DevicesAmendia, Inc.2016166—
+2K162138NuVasive CoRoent Small Ti-C SystemNu Vasive, Incorporated2016135—
+2K161405Valeo II Interbody Fusion Device SystemAmedica Corp.20164—
+2K160125Cascadia Interbody SystemK2m2016315—
+2K151310Amendia Interbody Fusion DevicesAmendia, Inc.2016169—
+3K250560BEE HANGMedical GmbH20250—
+3K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+3K250605EVOL® ha – Hyper C Cervical Interbody Fusion SystemCutting Edge Spine, LLC20250—
+3K241164IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic)202412
+3K241396uCerv Flux™-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA, Inc.20240—
+3K233191TotalTi ACDF by SAGICOSpinal Analytics & Geometrical Implant Co, LLC20230—
+3K230478Acro Composites Interbody SystemAcro Composites, LLC20230—
+3K231763Stable-C Interbody SystemNexus Spine, LLC20236—
+3K232150ZSFab Cervical Interbody SystemZsfab, Inc.20234—
+3K230607SPICCA Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+3K221138Titus Titanium Cervical by SAGICOSagico VA USA, LLC20231—
+3K231735NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody…Nu Vasive, Incorporated20239—
+3K223143SAGICO Spinal SystemSagico VA USA, LLC20230—
+3K230329F3D Interbody SystemCorelink, LLC20230—
+3K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+3K230851Kodiak Lumbar Spacer SystemMet One Technologies, LLC20230—
+3K213641MONDRIAN ALIF Cage with Supplementary Fixation PlateCtl Medical Corporation20221—
+3K220696uCerv Flux-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA20221—
+3K220523restor3d TiDAL Lumbar Interbody Fusion DeviceRestor3D20222—
+3K213980Peridot Spinal Interbody SystemGbs Commonwealth Co., Ltd.20224—
+3K212075ShurFit Lumbar Interbody SystemPrecision Spine, Inc.20211—
+3K211805IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec…Alphatec Spine, Inc.202138—
+3K211704CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini PTC Spacer…Orthofix, Inc.20215—
+3K210497SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202139—
+3K210044Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System…Spinal Elements, Inc.20211—
+3K203520Blustone Synergy Interbody Fusion SystemBlustone Synergy, LLC20210—
+3K203444BEE HA CageNGMedical GmbH20211—
+3K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+3K202488ZSFab Cervical Interbody SystemZsfab, Inc.20216—
+3K200458Tailored-C Cervical Interbody Fusion SystemBespoke Technologies20203—
+3K200549Lucero Medical Cervical Cage SystemLucero Medical, LLC20200—
+3K201193SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202018—
+3K202305Zavation IBF SystemZavation Medical Products, LLC20209—
+3K201939GAIA Lumbar Interbody Fusion Device (LIFD) FamilyPrinterprezz20200—
+3K201506Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical…Meditech Spine, LLC20200—
+3K201769Cavetto [MAX] Cervical Cage SystemNeurostructures, Inc.20200—
+3K191906MiRus 3D Printed Lumbar Interbody Fusion Systems consisting of the Callisto 3D Printed…MiRus, LLC20206—
+3K200052CONSTRUX Mini PTC Spacer System, FORZA PTC Spacer System, PILLAR SA PTC Spacer SystemOrthofix, Inc.202013—
+3K192497EVOL ha - D Lateral Interbody Fusion SystemCutting Edge Spine, LLC20201—
+3K193359SureMAX Family of Cervical SpacersAdditive Implants, Inc.202014—
+3K191477AEON-C Stand Alone SystemHuvexel Co., Ltd.201910—
+3K192582NuVasive CoRoent Small Interlock SystemNu Vasive, Incorporated201930—
+3K192208CORNICE Cervical Spacer SystemLegend Spine Technologies20190—
+3K191537eCarbon IBDsBack 2 Basics Direct, LLC20193—
+3K191243HEDRON Cervical SpacersGlobus Medical, Inc.201936—
+3K183064TxTi IBF SystemInnovasis, Inc.2019481
+3K182608Oyster ACIF CageSilony Medical GmbH20190—
+3K190618RIGEL PEEK Anterior Cervical Interbody Fusion SystemMiRus, LLC20191—
+3K183184FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.201912—
+3K183705IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc.201999—
+3K183083Shoreline Cervical Interbody RT SystemSeaSpine Orthopedics Corporation201960—
+3K182477Cervical SpacerAdditive Implants, LLC201915—
+3K180822VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion SystemWenzel Spine, Inc.20195—
+3K182284Tyber Medical PT Interbody SpacerTyber Medical, LLC20195—
+3K182210TiWAVE-L Porous Titanium Lumbar CageKalitec Medical, LLC20193—
+3K183239CoreLink F3D™ Lateral SystemCorelink, LLC20188—
+3K180909REVEL SpacersGlobus Medical, Inc.201837—
+3K181590Neurostructures Cavetto® [MAX] Cervical Cage SystemNeurostructures, Inc.20180—
+3K180814CoreLink® M3™ Stand-Alone Anterior Lumbar SystemCorelink, LLC201818—
+3K180556Corelink Foundation 3D Anterior Lumbar SystemCorelink, LLC20185—
+3K180401TiWAVE-C™ Porous Titanium Cervical CageKalitec Direct, LLC20185—
+3K180675Atlas Spine Expandable Cervical Interbody SystemAtlas Spine, Inc.20182—