BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Bigliani / Flatow (R) The Complete Shoulder Solution

    Reg #: 3010057495 · FEI: 3010057495 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    LH MEDICAL CORPORATION
    Registration Number
    3010057495
    FEI Number
    3010057495
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    6932 Gettysburg Pike
    City
    Fort Wayne
    State
    IN
    ZIP
    46804
    Country
    US

    Regulatory Submissions

    510(k) Number
    K110791

    Owner / Operator

    Firm Name
    LH Medical Corporation
    Operator Number
    10042802
    Address
    6932 Gettysburg Pike
    City
    Fort Wayne
    State
    IN
    Postal Code
    46804
    Country
    US
    Correspondent
    Ty Carpenter

    Products

    Device Name Product Code
    Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented KWT
    Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented HSD

    Proprietary Names

    Bigliani / Flatow (R) The Complete Shoulder Solution

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)