BEUDAMED
    FDA Registration Active 🇮🇹 Italy

    Winch Kyphoplasty 11 Gauge Balloon Catheters

    Reg #: 3010898856 · FEI: 3010898856 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    11
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    G21 S.R.I.
    Registration Number
    3010898856
    FEI Number
    3010898856
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Via S. Pertini, 8
    City
    San Possidonio Modena
    Country
    IT

    Regulatory Submissions

    510(k) Number
    K172214

    Owner / Operator

    Firm Name
    G21 s.r.l.
    Operator Number
    10051231
    Address
    Via S. Pertini, 8
    City
    San Possidonio
    State
    Modena
    Postal Code
    41039
    Country
    IT
    Correspondent
    Maurizio Foroni

    US Agent

    Business Name
    RQMIS, Inc.
    Contact Name
    Barry Sands
    Address
    110 Haverhill Road, Suite 524
    City
    Amesbury
    State
    MA
    ZIP
    01913
    Country
    US
    Email
    [email protected]
    Phone
    609 3728223

    Products

    Device Name Product Code
    Cement, Bone, Vertebroplasty NDN
    Arthroscope HRX

    Proprietary Names

    Winch Kyphoplasty 11 Gauge Balloon Catheters EasyWinch 15 mm WINCH BILATERAL KYPHOPLASTY KIT,15MM WINCH KYPHOPLASTY KIT, 15MM WINCH BILATERAL KYPHOPLASTY KIT,20MM WINCH KYPHOPLASTY KIT 8G, 20MM EasyWinch 20 mm WINCH KYPHOPLASTY KIT, 20MM WINCH BILATERAL KYPHOPLASTY KIT 8G, 20MM WINCH KYPHOPLASTY KIT 8G, 15MM WINCH BILATERAL KYPHOPLASTY KIT 8G, 15MM

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device