BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Equinoxe Fracture Plate

    Reg #: 3008658204 · FEI: 3008658204 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Exactech Sarasota
    Registration Number
    3008658204
    FEI Number
    3008658204
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    7455 16th Street East, Suite 105
    City
    Sarasota
    State
    FL
    ZIP
    34243
    Country
    US

    Regulatory Submissions

    510(k) Number
    K093978

    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
    Plate, Fixation, Bone HRS

    Proprietary Names

    Equinoxe Fracture Plate

    Establishment Types

    Manufacture Medical Device