BEUDAMED
    FDA Registration Active 🇺🇸 United States

    PARTIAL TILT TOP 4MM HEAD CENTERED

    Reg #: 1057421 · FEI: 1000022662 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    29
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    GRACE MEDICAL, INC.
    Registration Number
    1057421
    FEI Number
    1000022662
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    8500 WOLF LAKE DR. SUITE 110
    City
    Memphis
    State
    TN
    ZIP
    38133
    Country
    US

    Regulatory Submissions

    510(k) Number
    K972815

    Owner / Operator

    Firm Name
    GRACE MEDICAL GROUP, INC.
    Operator Number
    9067138
    Address
    8500 WOLF LAKE DR., SUITE 110
    City
    Memphis
    State
    TN
    Postal Code
    38133
    Country
    US

    Products

    Device Name Product Code
    Replacement, Ossicular Prosthesis, Total ETA
    Prosthesis, Partial Ossicular Replacement ETB

    Proprietary Names

    PARTIAL TILT TOP 4MM HEAD CENTERED PARTIAL TILT TOP 3.25MM HEAD NOTCHED STRASNICK TOTAL TILT-TOP 3MM HEAD TOTAL TILT TOP HEAD OFFSET WEHRS SINGLE NOTCH INCUS-STAPES WEHRS SINGLE NOTCH INCUS PARTIAL TILT TOP 3.50MM HEAD OFFSET WEHRS DOUBLE NOTCH INCUS-STAPES TOTAL TILT TOP HEAD NOTCHED WEHRS DOUBLE NOTCH INCUS PARTIAL TILT TOP 3MM HEAD CENTERED TOTAL TILT TOP HEAD VINCENT TYPE PARTIAL 4MM HEAD NOTCHED TOTAL TILT TOP HEAD CENTERED PARTIAL 4MM CENTERED HEAD K-HELIX FOOTPLATE SHOE STRANICK PARTIAL TILT-TOP 3MM HEAD PARTIAL 4MM HEAD OFFSET PARTIAL TILT TOP 4MM HEAD OFFSET PARTIAL TILT TOP HEAD VINCENT TYPE PARTIAL TILT TOP 3.50MM HEAD NOTCHED Grace Medical VINCENT TOTAL PARTIAL 3MM CENTERED HEAD PARTIAL TILT TOP 4MM HEAD NOTCHED PARTIAL TILT TOP 3.25MM HEAD OFFSET BOJRAB UNIVERSAL UNIVERSAL PROSTHESIS DORNHOFFER FOOTPLATE SHOE

    Establishment Types

    Manufacture Medical Device