BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    Merete Cannulated PCS

    Reg #: 3014314623 · FEI: 3014314623 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    5
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Aristotech Industries GmbH
    Registration Number
    3014314623
    FEI Number
    3014314623
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Alt-Lankwitz 102
    City
    Berlin
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K152187

    Owner / Operator

    Firm Name
    Aristotech Industries GmbH
    Operator Number
    10053573
    Address
    Im Biotechnologiepark
    City
    Luckenwalde
    State
    Brandenburg
    Postal Code
    14943
    Country
    DE
    Correspondent
    Jens-Erik Wegner

    Products

    Device Name Product Code
    Screw, Fixation, Bone HWC
    Plate, Fixation, Bone HRS

    Proprietary Names

    Merete Cannulated PCS TwistCut" Snap-Off Screws Merete CS Cortical Screws MetaFix" LS Locking Screws Merete Cannulated HCS

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)