BEUDAMED
    FDA Registration Active 🇬🇧 United Kingdom

    Confidence High Viscosity Spinal Cement

    Reg #: 3009421413 · FEI: 3009421413 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    GMED Healthcare BV (a Johnson & Johnson Company)
    Registration Number
    3009421413
    FEI Number
    3009421413
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Capitol Boulevard, Capital Park West
    City
    Leeds
    Country
    GB

    Regulatory Submissions

    510(k) Number
    K112907

    Owner / Operator

    Firm Name
    DePuy Synthes, Inc.
    Operator Number
    1818910
    Address
    700 Orthopaedic Drive
    City
    Warsaw
    State
    IN
    Postal Code
    46582
    Country
    US

    US Agent

    Business Name
    DEPUY SYNTHES, INC.
    Contact Name
    Erin Combs
    Address
    700 Orthopaedic Drive
    City
    Warsaw
    State
    IN
    ZIP
    46582
    Country
    US
    Email
    [email protected]
    Phone
    574 4048348

    Products

    Device Name Product Code
    Cement, Bone, Vertebroplasty NDN

    Proprietary Names

    Confidence High Viscosity Spinal Cement

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device