BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    VERTICALE POSTERIOR SPINAL FIXATION SYSTEM OPEN

    Reg #: 3012764194 · FEI: 3012764194 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Silony Medical International AG
    Registration Number
    3012764194
    FEI Number
    3012764194
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Leinfelder Strasse 60
    City
    Leinfelden Echterdingen Baden-Wurttemberg
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K171421

    Owner / Operator

    Firm Name
    Silony Medical
    Operator Number
    10054311
    Address
    Leinfelder Strasse 60
    City
    Leinfelden-Echterdingen
    State
    Baden-Wurttemberg
    Postal Code
    70771
    Country
    DE

    US Agent

    Business Name
    RAF SOLUTIONS USA, INC
    Contact Name
    Edwin Lindsay
    Address
    10124 N.W. 53rd Street, Sunrise
    City
    Fort Lauderdale
    State
    FL
    ZIP
    33351
    Country
    US
    Email
    [email protected]
    Phone
    305 9607262

    Products

    Device Name Product Code
    Appliance, Fixation, Spinal Interlaminal KWP
    Thoracolumbosacral Pedicle Screw System NKB

    Proprietary Names

    VERTICALE POSTERIOR SPINAL FIXATION SYSTEM OPEN VERTICALE POSTERIOR SPINAL FIXATION SYSTEM MIS

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device