BEUDAMED
    FDA Registration Active 🇺🇸 United States

    TriALTIS™ Spine System

    Reg #: 1526439 · FEI: 1526439 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    DEPUY SPINE, INC.
    Registration Number
    1526439
    FEI Number
    1526439
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    325 Paramount Drive
    City
    RAYNHAM
    State
    MA
    ZIP
    02767
    Country
    US

    Regulatory Submissions

    510(k) Number
    K243249

    Owner / Operator

    Firm Name
    DePuy Spine, Inc.
    Operator Number
    1526439
    Address
    325 Paramount Drive
    City
    Raynham
    State
    MA
    Postal Code
    02767
    Country
    US
    Correspondent
    Karen Parker

    Products

    Device Name Product Code
    Thoracolumbosacral Pedicle Screw System NKB
    Bone Cement, Posterior Screw Augmentation PML

    Proprietary Names

    TriALTIS™ Spine System

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility