BEUDAMED
    FDA Registration Active 🇺🇸 United States

    CORE Shoulder System

    Reg #: 3003018722 · FEI: 3003018722 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ENERCON TECHNOLOGIES
    Registration Number
    3003018722
    FEI Number
    3003018722
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    25 NORTHBROOK DR., P.O. BOX 665
    City
    GRAY
    State
    ME
    ZIP
    04039
    Country
    US

    Regulatory Submissions

    510(k) Number
    K241470

    Owner / Operator

    Firm Name
    ENERCON TECHNOLOGIES
    Operator Number
    9051058
    Address
    25 NORTHBROOK DR., P.O. BOX 665
    City
    Gray
    State
    ME
    Postal Code
    04039
    Country
    US

    Products

    Device Name Product Code
    Shoulder Arthroplasty Implantation System QHE

    Proprietary Names

    CORE Shoulder System

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)