BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Global Unite Platform Shoulder System

    Reg #: 1221934 · FEI: 1221934 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    DePuy Mitek, Inc.
    Registration Number
    1221934
    FEI Number
    1221934
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    325 Paramount Dr
    City
    RAYNHAM
    State
    MA
    ZIP
    02767
    Country
    US

    Regulatory Submissions

    510(k) Number
    K212710

    Owner / Operator

    Firm Name
    DEPUY MITEK, A JOHNSON & JOHNSON COMPANY
    Operator Number
    1221934
    Address
    4600 Riverside Drive, --
    City
    Palm Beach Gardens
    State
    FL
    Postal Code
    33410
    Country
    US
    Correspondent
    Karen Parker

    Products

    Device Name Product Code
    Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented HSD
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented KWS
    Shoulder Prosthesis, Reverse Configuration PHX

    Proprietary Names

    Global Unite Platform Shoulder System

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility