BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Catalyst R1 Reverse Shoulder System

    Reg #: 3012552981 · FEI: 3012552981 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    CATALYST ORTHOSCIENCE Inc
    Registration Number
    3012552981
    FEI Number
    3012552981
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    14710 Tamiami Trail N., Suite #102
    City
    Naples
    State
    FL
    ZIP
    34110
    Country
    US

    Regulatory Submissions

    510(k) Number
    K213349

    Owner / Operator

    Firm Name
    Catalyst Orthoscience
    Operator Number
    10051942
    Address
    14710 Tamiami Trail N., Suite #102
    City
    Naples
    State
    FL
    Postal Code
    34110
    Country
    US
    Correspondent
    Dale Davison

    Products

    Device Name Product Code
    Shoulder Prosthesis, Reverse Configuration PHX
    Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented HSD

    Proprietary Names

    Catalyst R1 Reverse Shoulder System

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility