BEUDAMED
    FDA Registration Active 🇫🇮 Finland

    ActivaScrew Cannulated

    Reg #: 3005536892 · FEI: 3005536892 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Bioretec Ltd.
    Registration Number
    3005536892
    FEI Number
    3005536892
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Yrittajankulma 5
    City
    Tampere Pirkanmaa
    Country
    FI

    Regulatory Submissions

    510(k) Number
    K081392

    Owner / Operator

    Firm Name
    Bioretec Ltd.
    Operator Number
    9093133
    Address
    Yrittajankulma 5
    City
    Tampere
    State
    FI-NOTA
    Postal Code
    FI-33710
    Country
    FI
    Correspondent
    Mari S Ruotsalainen

    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
    Screw, Fixation, Bone HWC

    Proprietary Names

    ActivaScrew Cannulated ActivaScrew

    Establishment Types

    Manufacture Medical Device