BEUDAMED
    FDA Registration Active 🇺🇸 United States

    OPTETRAK UNICONDYLAR KNEE

    Reg #: 3014399756 · FEI: 3014399756 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Exactech Sarasota Molding
    Registration Number
    3014399756
    FEI Number
    3014399756
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1189 Tallevast Road
    City
    Sarasota
    State
    FL
    ZIP
    34243
    Country
    US

    Regulatory Submissions

    510(k) Number
    K040889

    Owner / Operator

    Firm Name
    EXACTECH, INC.
    Operator Number
    1038671
    Address
    2320 N.W. 66TH CT., --
    City
    Gainesville
    State
    FL
    Postal Code
    32653
    Country
    US

    Products

    Device Name Product Code
    Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer HRY

    Proprietary Names

    OPTETRAK UNICONDYLAR KNEE

    Establishment Types

    Manufacture Medical Device