BEUDAMED
    FDA Registration Active 🇮🇹 Italy

    MEDACTA TOTAL HIP PROTHESIS SYSTEM-AMISTEN H QUADRA H QUADRA S

    Reg #: 9681465 · FEI: 3002807113 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Gammatom S.r.l.
    Registration Number
    9681465
    FEI Number
    3002807113
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    VIA XXIV MAGGIO, 14
    City
    GUANZATE (CO) Como
    Country
    IT

    Regulatory Submissions

    510(k) Number
    K093944

    Owner / Operator

    Firm Name
    GAMMATOM Srl
    Operator Number
    9023536
    Address
    VIA XXIV MAGGIO, 14, --
    City
    GUANZATE
    State
    Como
    Postal Code
    22070
    Country
    IT
    Correspondent
    Andrea - Soldini

    US Agent

    Business Name
    Donawa Consulting LLC
    Contact Name
    Stephen H. Lieberman
    Address
    4545 N. Ocean Blvd., Unit 11A
    City
    Boca Raton
    ZIP
    33431
    Country
    US
    Email
    [email protected]
    Phone
    561 3020777 ext. 0

    Products

    Device Name Product Code
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented LZO

    Proprietary Names

    MEDACTA TOTAL HIP PROTHESIS SYSTEM-AMISTEN H QUADRA H QUADRA S

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)