BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Catalyst R1 Reverse Shoulder System

    Reg #: 3033273230 · FEI: 3033273230 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    BIOS
    Registration Number
    3033273230
    FEI Number
    3033273230
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1295 Nesbit Drive
    City
    Nesbit
    State
    MS
    ZIP
    38651
    Country
    US

    Regulatory Submissions

    510(k) Number
    K223655

    Owner / Operator

    Firm Name
    BIOS
    Operator Number
    10091714
    Address
    1295 Nesbit Drive
    City
    Nesbit
    State
    MS
    Postal Code
    38651
    Country
    US
    Correspondent
    Carey Bryant

    Products

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

    Proprietary Names

    Catalyst R1 Reverse Shoulder System

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)