BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Sintea USA

    Reg #: 1066481 · FEI: 3003428720 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    SINTEA PLUSTEK, LLC
    Registration Number
    1066481
    FEI Number
    3003428720
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    407 Lincoln Road Suite 11B
    City
    Miami Beach
    State
    FL
    ZIP
    33139
    Country
    US

    Regulatory Submissions

    510(k) Number
    K070181

    Owner / Operator

    Firm Name
    Sintea USA, LLC
    Operator Number
    10031158
    Address
    407 Lincoln Road, Suite 11B
    City
    Miami Beach
    State
    FL
    Postal Code
    33139
    Country
    US
    Correspondent
    Guido Zorzoli

    Products

    Device Name Product Code
    Appliance, Fixation, Spinal Intervertebral Body KWQ
    Spinal Vertebral Body Replacement Device MQP

    Proprietary Names

    Sintea USA

    Establishment Types

    Manufacture Medical Device