510(k) Report

Devices descending from K023835

1,227 later devices reach Devex Mesh System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K190092UNiD Patient specific 3D printed TLIF cageMedicrea International SA201913—
+5K190165Capstone Control™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20196—
+5K182877HALF DOME Posterior Lumbar Interbody SystemAstura Medical, LLC201921—
+5K183184FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.201912—
+5K183426MectaLIF Anterior Stand Alone ExtensionMedacta International S.A.20191—
+5K190055Duo Lumbar Interbody Fusion DeviceSpineology, Inc.20191—
+5K190193SpineEX Sagittae® Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20192—
+5K183049Reliance Lumbar IBF SystemReliance Medical Systems, LLC20197—
+5K183083Shoreline Cervical Interbody RT SystemSeaSpine Orthopedics Corporation201960—
+5K183557Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device…Titan Spine, Inc.20191043
+5K181048Neo Cage System TMNeo Medical SA20191—
+5K180822VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion SystemWenzel Spine, Inc.20195—
+5K181118Reliance Lumbar IBF SystemReliance Medical Systems20190—
+5K180665SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage SystemK2m, LLC20189—
+5K182015Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20181—
+5K181818Scarlet AL-TSpineart201864—
+5K181229TirboLOX-C Cervical IBFDCaptiva Spine, Inc.20180—
+5K181655Renovis S180 Lateral Lumbar Interbody Fusion SystemRenovis Surgical Technologies20184—
+5K181295Genesys Spine AIS-C Cervical Stand-Alone SystemGenesys Spine201817—
+5K181483Tranquil Interbody SystemNexus Spine, LLC20186—
+5K181435ATEC Cervical Spacer SystemAlphatec Spine, Inc.2018100—
+5K180777K2M Expandable Interbody SystemK2m, Inc.20180—
+5K181030Rubicon Lumbar Interbody Fusion SystemRubicon Spine, LLC20180—
+5K181115CxHA PEEK Cervical IBF SystemInnovasis, Inc.20188—
+5K181246Zavation IBF SystemZavation Medical Products, LLC201822—
+5K181261Curiteva Cervical Interbody Fusion SystemCuriteva, LLC20184—
+5K181203Juliet TiSpineart20181—
+5K180364HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC2018106—
+5K180480ATEC Universal Spacer SystemAlphatec Spine, Inc.2018113—
+5K173832InTice™-C Porous Ti Cervical Interbody SystemX-Spine Systems, Inc.201801
+5K180519HARRIER-SA™ Lumbar Interbody SystemChoicespine, LP20180—
+5K173892NuVasive® XLX Interbody SystemNu Vasive, Incorporated2018115—
+5K180071STYLO Interbody Fusion DeviceLegend Spine Technologies20180—
+5K173782UNiD Patient Specific 3D printed cageMedicrea International SA201823—
+5K180078Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF SystemInnovasis, Inc.2018551
+5K171495Zyston Strut Open Titanium Spacer SystemZimmer Biomet Spine, Inc.20181—
+5K173283Reliance Lumbar IBF SystemReliance Medical Systems, LLC20189—
+5K172696FORZA® XP Expandable Spacer SystemOrthofix, Inc.201825—
+5K173702Juliet Ti LLSpineart20182—
+5K173102Reliance Cervical IBF SystemReliance Medical Systems, LLC201715—
+5K173652Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20170—
+5K171848FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO…Globus Medical, Inc.201755—
+5K173115COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and…Globus Medical, Inc.201783—
+5K170389TAURUS PEEK Cage SystemMedyssey USA, Inc.20170—
+5K172676NuVasive® Modulus-C Interbody SystemNu Vasive, Incorporated2017125—
+5K172419Velofix™ TLIF CageU&I Corporation20172—
+5K172083Idys™ ALIF SystemClariance, Sas20177—
+5K172392Lateral Spinal Truss System (LSTS) Interbody Fusion Device4Web, Inc.20171—
+5K172437CONSTRUX® Mini PTC Spacer System, FORZA® PTC Spacer System, PILLAR® SA PTC Spacer SystemOrthofix, Inc.2017143
+5K173080IVA Cage Ti (ACIF, PLIF, TLIF, DLIF, and ALIF)Huvexel Co., Ltd.20172—
+5K171489Acapella Cervical Spacer SystemChoicespine, LP201739—
+5K172123NuVasive® Modulus XLIF Interbody SystemNu Vasive, Incorporated2017227—
+5K163366Shanghai Sanyou CARMEN Cervical Fusion SystemShanghai Sanyou Medical Co, Ltd.20170—
+5K170157INDEPENDENCE® SpacersGlobus Medical, Inc.2017109—
+5K172199ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT…Medtronic Sofamor Danek20176—
+5K171351Posterior Spine Truss System (PSTS) Interbody Fusion Device4Web, Inc.20177—
+5K171704CAPRI Corpectomy Cage SystemK2m201710—
+5K171567IRIX-A Lumbar Integrated Fusion SystemX-Spine Systems, Inc.201701
+5K170851Anterior Spine Truss System (STS) Interbody Fusion Device4Web, Inc.20175—
+5K170503EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular…Eit Emerging Implant Technologies GmbH20171992
+5K171046SeaSpine Cambria SystemSeaSpine Orthopedics Corporation201762—
+5K170844Gemini-C Hybrid Cervical Interbody SystemOsseus Fusion Systems, LLC20170—
+5K161710Sagico Ibf System – Aria Lumbar, Sagico Ibf System – Arion CervicalSpinal Analytics & Geometrical Impant Co, LLC201741—
+5K170961NuVasive CoRoent Small Interlock II SystemNu Vasive, Incorporated201718—
+5K170395Talos® Lumbar (HA) PEEK IBF DevicesMeditech Spine, LLC201710—
+5K163673Fortilink™-C with TETRAfuse™ 3D TechnologyRti Surgical, Inc.201711—
+5K162212Divergence-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc.201757—
+5K170401Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20173—
+5K171097MOJAVE Expandable Interbody SystemK2m, Inc.201717—
+5K162496Foundation 3D InterbodyCorelink, LLC201782—
+5K170592NuVasive BASE Interfixated Titanium SystemNu Vasive, Incorporated2017186—
+5K163581Navigated ELEVATE Inserter, Navigated Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.2017103—
+5K162206Zavation IBFZavation, LLC201724—
+5K170455MectaLIF Anterior Stand AloneMedacta International S.A.20174—
+5K162879Elite Expandable Interbody Fusion DeviceSpineology, Inc.20179—
+5K162680SOVEREIGN® Spinal SystemMedtronic Sofamor Danek USA, Inc.201631—
+5K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation201679—
+5K162103Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine…Choicespine, LP2016161—
+5K161993Leva® Anterior Interbody SystemSpine Wave, Inc.20160—
+5K162944Irix-C Cervical Integrated Fusion SystemX-Spine Systems, Inc.20161—
+5K160076XCage™ Interbody Fusion SystemOuroboros Medical, Inc.2016141
+5K160958Battalion Universal Spacer SystemAlphatec Spine2016114—
+5K161230NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated2016381—
+5K161404Genesys Spine Apache® Lateral Lumbar Interbody Fusion SystemGenesys Spine201610—
+5K160906Rampart O Lumbar Interbody Fusion Device, Rampart T Lumbar Interbody Fusion Device…Spineology, Inc.201627—
+5K153105MLX™ - Medial Lateral Expandable Lumbar Interbody SystemNu Vasive, Incorporated2016234—
+5K152622Alta ACDF SystemBiomet Spine20160—
+5K152501Spinal Jaxx Interbody Fusion DeviceNeuropro Spinaljaxx, Inc.201601
+5K160995NEOVIEW Plating SystemIn2bones Sas201624
+5K153436LATERAL Spine Truss System4Web, Inc.20165—
+5K153107Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine VEO™…Choicespine, LP2016171—
+5K153123Genesys Spine Apache Interbody Fusion SystemGenesys Spine201612—
+5K153419NuVasive CoRoent Thoracolumbar SystemNu Vasive, Incorporated2016400—
+5K151665SUSTAIN Additional ImplantsGlobus Medical, Inc.2016119—
+5K160002Piccolo Composite (R) Distal Volar Radius Plate SystemCarboFix Orthopedics, Ltd.20164—
+5K152568C-VBRCardinal Spine, LLC201657—
+5K152620Spine Wave Gen II Expandable Interbody SystemSpine Wave, Inc.20162—
+5K153356Spine Innovation Interbody SystemSpine Innovation, LLC20161—
+5K151312VerteLP Interbody Fusion DeviceVgi, LLC201601
+5K153536Piccolo Composite® Nailing SystemCarboFix Orthopedics, Ltd.201611