BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Titan Spine, a Division of Medtronic

    Reg #: 3011577940 · FEI: 3011577940 · Expires 2026
    View on FDA
    Products
    30
    Proprietary Names
    49
    Establishment Types
    3
    Classifications
    30

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    Registration Details

    Registration Name
    Titan Spine, a Division of Medtronic
    Registration Number
    3011577940
    FEI Number
    3011577940
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    8347 N Steven Rd
    City
    Milwaukee
    State
    WI
    ZIP
    53223
    Country
    US

    Regulatory Submissions

    510(k) Number
    K191565

    Owner / Operator

    Firm Name
    Medtronic, Inc.
    Operator Number
    2112641
    Address
    710 Medtronic Parkway
    City
    Minneapolis
    State
    MN
    Postal Code
    55432
    Country
    US

    Products

    Device Name Product Code
    Rongeur HTX
    Bit, Drill HTW
    Intervertebral Fusion Device With Integrated Fixation, Cervical OVE
    Appliance, Fixation, Spinal Interlaminal KWP
    Thoracolumbosacral Pedicle Screw System NKB
    Appliance, Fixation, Spinal Intervertebral Body KWQ
    Extractor HWB
    Elevator HTE
    Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis OSH
    Orthosis, Spinal Pedicle Fixation MNI
    Orthosis, Spondylolisthesis Spinal Fixation MNH
    Intervertebral Fusion Device With Integrated Fixation, Lumbar OVD
    Spinal Vertebral Body Replacement Device MQP
    Intervertebral Fusion Device With Bone Graft, Lumbar MAX
    Intervertebral Fusion Device With Bone Graft, Cervical ODP
    Curette HTF
    Template HWT
    Impactor HWA
    Orthopedic Stereotaxic Instrument OLO
    Rasp HTR
    Drills, Burrs, Trephines & Accessories (Simple, Powered) HBE
    Screwdriver HXX
    Osteotome HWM
    Orthopedic Manual Surgical Instrument LXH
    Electrode, Needle GXZ
    Sterilization Wrap Containers, Trays, Cassettes & Other Accessories KCT
    Mallet HXL
    Tamp HXG
    Awl HWJ
    Tray, Surgical LRP

    Proprietary Names

    NO 8 HEXALOBE STRAIGHT DRIVER MULTIPLE TWIST Drill; Introducer Tool MICRO-FRANCE BIT DRILLS DRILL BIT (ORTHOPEDIC MA Endoskeleton TCS Interbody Fusion Device CD Horizon ModuLeX Spinal System - Degen Scoli Phase 2 MULTIPLE (DRIVER-EXTRACTORS) IB3D™ PL Spinal System ELEVATOR CD Horizon Spinal System Endoskeleton(R) TAS Interbody Fusion Device / Endoskeleton(R) TAS Hyperlordotic Interbody Fusion Device ENDOSKELETON; TA IBD AND VBR, TO AND TT, TAS, TC, TL Curette Endoskeleton TCS System TEMPLATE Medtronic Reusable Instrument Adaptix™ Interbody System with Titan nanoLock™ Surface Technology ENDOSKELETON(R) TL INTERBODY FUSION DEVICE ENDOSKELETON TA VERTEBRAL BODY REPLACEMENT ENDOSKELETON® TA nanoLOCK® Surface Technology ENDOSKELETON TO Rasp CD Horizon™ ModuLeX™ Spinal System Endoskeleton® TO ENDOSKELETON(R) TAS Endoskeleton(R) TCS System ENDOSKELETON TT INTERBODY FUSION DEVICE (IBD) SCREWDRIVER MULTIPLE (ORTHOPEDIC OSTEOTOMES) General Instrument PASS LP Spinal System Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion Device Endoskeleton TAS Plate ENDOSKELETON TA INTERBODY FUSION DEVICE (IBD ENDOSKELETON® TL Medtronic Transportation_Sterilization Cassettes SHILLA™ Growth Guidance System Catalyft™ LS Expandable Interbody System ENDOSKELETON TC MULTIPLE (SURGICAL MALLETS) Anteralign™ Spinal system with Titan nanoLOCK™ Surface Technology CD Horizon™ ModuLeX™ Fenestrated Screw Set Anteralign Spinal System with Titan nanolOCk Medtronic General Instrument TRAY, SURGICAL Endoskeleton® TAS Interbody Fusion Device Endoskeleton® TAS Hyperlordotic Interbody Fusion Device And Endoskeleton® TCS Interbody Fusion Device

    Establishment Types

    Manufacture Medical Device Repack or Relabel Medical Device Develop Specifications But Do Not Manufacture At This Facility