510(k) Report

Devices descending from K003043

1,819 later devices reach Surgical Titanium Mesh System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K140411Altera SpacerGlobus Medical, Inc.201419122
+6K133494Chesapeake Spinal SystemK2m, Inc.2014330—
+6K140529Everest Spinal SystemK2m, LLC201431—
+6K133418Integra Expandable Interverebral Body Fusion Device (Ibd) SystemSeaspine, Inc.20145—
+6K133514Xcage Interbody Fusion SystemOuroboros Medical201415—
+6K140303Alamo TAlliance Partners, LLC20140—
+6K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—
+6K133893Sterispine LC CageSafe Orthopaedics20141—
+6K132926Velofixtm Interbody Fusion SystemU&I Corp.201410—
+6K131276Lateral SynfixSynthes (USA) Products, LLC2014146—
+6K132757Everest Spinal SystemK2m, Inc.201341—
+6K130853Idys (TM) CClariance20132—
+6K132361Everest Spinal SystemK2m, Inc.201334—
+6K131723Coroent Single Tab SystemNuvasive, Inc.2013466—
+6K130948C-Fuse Cervical Intervertebral Body Fusion SystemSouthern Spine, LLC201313—
+6K124012Infill Oblique Tlif DevicePinnacle Spine Group, LLC20136—
+6K122801Providence Cervical CageProvidence Medical Technology, Inc.20131—
+6K130506Imse P-TlifInstitute of Musculoskeletal Science & Education20130—
+6K123461Staxx (R) IB SystemSpine Wave, Inc.2013251
+6K130306Incite Anchored Cervical Interbody DeviceIncite Innovation, LLC20131—
+6K123993Solus Anterior Lumbar Interbody Fusion (Alif) SystemAlphatec Spine, Inc.20130—
+6K120603Varilift -CWenzel Spine2013193—
+6K123231Caliber SpacersGlobus Medical, Inc.2013657—
+6K121254Camber Spine Technologies TLS 5.0 Inerbody CageCamber Spine Technologies201340—
+6K123180Falcon SpacerSynthes (USA) Products, LLC2013147—
+6K122956Fuselox Lumbar Interbody Fusion DeviceCaptiva Spine20122—
+6K113285LDR Spine Usa Avenue L Interbody FusionLdr Spine USA, Inc.2012199—
+6K121733Infill Intervertebral Body Fusion DevicePinnacle Spine Group, LLC201221—
+6K120275Synthes Acis/Vertebral Spacer CRSynthes (Usa), LLC2012173—
+6K120368Capstone Control Spinal SystemMedtronic Sofamor Danek USA, Inc.2012761—
+6K120101Independence SpacerGlobus Medical, Inc.2012224—
+6K113447Rise SpacerGlobus Medical, Inc.2012691—
+6K113527Opticage Interbody Fusion DeviceInterventional Spine, Inc.2012103—
+6K113465Acculif TL CageCoalign Innovations, Inc.2011718—
+6K112095Acculif TL-Peek Ibf CageCoalign Innovations, Inc.2011319—
+6K111439Chesapeake (Cervical Components)K2m, Inc.20113451
+6K100967Perimeter C Spinal SystemMedtronic Sofamor Danek USA, Inc.2011121—
+6K111675VU C*Pod Intervertebral Body Fusion DeviceTheken Spine, LLC201162—
+6K092211Chesapeake Spinal SystemK2m, Inc.2010450—
+6K082698Aleutian Ibf SystemK2m, Inc.2009662—
+6K081849Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc.20087531
+6K072120Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc.20071,405—
+6K063399Aleutian Spacer SystemK2m, Inc.2007663—
+6K060350Construx PL/TL Peek Partial VBR SystemBlackstone Medical, Inc.2006754—
+7K263049SABER-C SystemElevation Spine20260—
+7K262025Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis…INNO Holdings Inc. DBA Innovasis20260—
+7K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc.20260—
+7K262489BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20260—
+7K262094E3D™-C Interbody SystemEvolution Spine20260—
+7K261279DeltaNEC Interbody SystemNexus Spine20260—
+7K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+7K260810Anteralign LS coverplateTyber Medical, LLC20260—
+7K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, Inc.20260—
+7K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—
+7K252774Uni-C Cervical Cage SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+7K260340HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC…HC Biologics, LLC20260—
+7K253583LUX Expandable Lumbar Interbody SystemXenix Medical20260—
+7K253545Vulcan Spinal SystemK2m, Inc.20260—
+7K251479Mobarn 80:20 Lumbar Interbody Fusion System (Posterior Lumbar Interbody Fusion Cage…Mobarn Medical Devices, LLC20250—
+7K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+7K251850Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20251—
+7K241525ExcelsiusXR™Globus Medical, Inc.20250—
+7K243816Testa TP Pivoting Spacer SystemSpine Wave, Inc.20250—
+7K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+7K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—
+7K251117Cervical Spine Truss System (CSTS)4Web Medical20250—
+7K250669Adaptix™ Interbody System with Titan nanoLOCK™ Surface TechnologyMedtronic Sofamor Danek USA, Inc.20250—
+7K250521NanoBone® SBX Putty ; NanoBone® QDBiocomposites, Ltd.20250—
+7K250556Porous Biologic ScaffoldVentris Medical20250—
+7K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+7K243739AxCess® Expandable Interbody SystemElliquence, LLC20250—
+7K243706Mastergraft Matrix EXT; Mastergraft Strip; Mastergraft Putty; Mastergraft GranulesMedtronic Sofamor Danek, Inc.20250—
+7K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+7K241167BioSphere Putty; BioSphere MIS PuttySynergy Biomedical20240—
+7K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+7K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+7K241477aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20246—
+7K242457EARP Interbody SystemRetropsoas Technologies, LLC20240—
+7K242299NovaBone Putty - Synthetic Bioactive Bone GraftNovabone Products, LLC20241—
+7K242273Cove Putty, OsteoCove PuttySeaSpine Orthopedics Corporation202402
+7K241332aprevo® anterior and lateral lumbar interbody fusion device; aprevo® anterior lumbar…Carlsmed, Inc.20245—
+7K232996Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF)Shanghai Iatrical-Ti Technologies CO, Ltd.20240—
+7K241738PYXIS 3D Titanium Cervical Cage systemGS Medical Co., Ltd.20241—
+7K241328aprevo® Anterior and Lateral Lumbar Interbody Fusion device (ALIF/LLIF); aprevo®…Carlsmed, Inc.20240—
+7K241321Juliet® Ti LL Lumbar Interbody DeviceSpineart SA20240—
+7K241019aprevo® TLIF-C Articulating SystemCarlsmed20244—
+7K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+7K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+7K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+7K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+7K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+7K240442MagnetOs PuttyKuros Biosciences B.V20243—
+7K232282aprevo® anterior and lateral lumbar interbody fusion device, aprevo® transforaminal…Carlsmed, Inc.20240—
+7K240507NuVasive AttraX ScaffoldNuvasive, Inc.20240—
+7K233359DOMINION Expandable Corpectomy SystemAstura Medical20242—
+7K240458Synthetic Bone PuttyVentris Medical20242—
+7K240459Cerament Bone Void FillerBonesupport AB20240—
+7K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+7K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+7K232347MagnetOs GranulesKuros Biosciences B.V20242—