BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Inset Reverse Total Shoulder System

    Reg #: 3012544635 · FEI: 3012544635 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    SHOULDER INNOVATIONS, Inc
    Registration Number
    3012544635
    FEI Number
    3012544635
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1535 Steele Ave SW, Suite B
    City
    Grand Rapids
    State
    MI
    ZIP
    49507
    Country
    US

    Regulatory Submissions

    510(k) Number
    K210533

    Owner / Operator

    Firm Name
    Shoulder Innovations, Inc
    Operator Number
    10051976
    Address
    1535 Steele Ave SW Suite B
    City
    Grand Rapids
    State
    MI
    Postal Code
    49507
    Country
    US

    Products

    Device Name Product Code
    Shoulder Prosthesis, Reverse Configuration PHX
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented MBF

    Proprietary Names

    Inset Reverse Total Shoulder System

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility