BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SHOULDER INNOVATIONS, Inc

    Reg #: 3012544635 · FEI: 3012544635 · Expires 2026
    View on FDA
    Products
    6
    Proprietary Names
    5
    Establishment Types
    2
    Classifications
    6

    Registration Details

    Registration Name
    SHOULDER INNOVATIONS, Inc
    Registration Number
    3012544635
    FEI Number
    3012544635
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    1535 Steele Ave SW, Suite B
    City
    Grand Rapids
    State
    MI
    ZIP
    49507
    Country
    US

    Regulatory Submissions

    510(k) Number
    K192365

    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
    Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented KWT
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented KWS
    Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented HSD
    Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained PKC
    Shoulder Prosthesis, Reverse Configuration PHX
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented MBF

    Proprietary Names

    Shoulder Innovations Total Shoulder System Shoulder Innovations Total Shoulder Replacement System Inset Reverse Total Shoulder System InSet Total Shoulder System Humeral Short Stem System

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Repack or Relabel Medical Device