BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Ingen Total Shoulder System

    Reg #: 3005130928 · FEI: 3005130928 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    INGEN ORTHOPEDICS LLC
    Registration Number
    3005130928
    FEI Number
    3005130928
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    68 Mussey Road
    City
    Scarborough
    State
    ME
    ZIP
    04074
    Country
    US

    Regulatory Submissions

    510(k) Number
    K043346

    Owner / Operator

    Firm Name
    Ingen Orthopedics LLC
    Operator Number
    9072056
    Address
    68 Mussey Road
    City
    Scarborough
    State
    ME
    Postal Code
    04074
    Country
    US
    Correspondent
    JOSEPH - AZARY

    Products

    Device Name Product Code
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented KWS

    Proprietary Names

    Ingen Total Shoulder System

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility