BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    Z1 Hip System

    Reg #: 3010206549 · FEI: 3010206549 · Expires 2025
    View on FDA
    Products
    5
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    5

    Registration Details

    Registration Name
    ARISTOTECH INDUSTRIES GMBH
    Registration Number
    3010206549
    FEI Number
    3010206549
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Im Biotechnologiepark
    City
    Luckenwalde Brandenburg
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K233476

    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
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented LZO
    Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer KWZ
    Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented KWY
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented LWJ
    Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate MEH

    Proprietary Names

    Z1 Hip System

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)