BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    CERAMTEC GmbH Medical Products Division

    Reg #: 3001278222 · FEI: 3001278222 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    0
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    CERAMTEC GmbH Medical Products Division
    Registration Number
    3001278222
    FEI Number
    3001278222
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    CeramTec - Weg 1
    City
    MARKTREDWITZ Bavaria
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K981847

    Owner / Operator

    Firm Name
    CeramTec GmbH
    Operator Number
    9066049
    Address
    CeramTec-Platz 1-9
    City
    Plochingen
    State
    Baden-Wurttemberg
    Postal Code
    D-73207
    Country
    DE
    Correspondent
    Stefan - Ruck

    US Agent

    Business Name
    CeramTec GmbH
    Contact Name
    Lindsay Stafford
    Address
    1350 N Santorini Dr
    City
    Warsaw
    State
    IN
    ZIP
    46580
    Country
    US
    Email
    [email protected]
    Phone
    864 6842253

    Products

    Device Name Product Code
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented LZO

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)