BEUDAMED
    FDA Registration Active 🇨🇭 Switzerland

    Polarstem

    Reg #: 3010363503 · FEI: 3010363503 · Expires 2025
    View on FDA
    Products
    4
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    FRUEH VERPACKUNGSTECHNIK AG
    Registration Number
    3010363503
    FEI Number
    3010363503
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Allmendstrasse 47
    City
    Fehraltorf Zurich
    Country
    CH

    Regulatory Submissions

    510(k) Number
    K143739

    Owner / Operator

    Firm Name
    Frueh Verpackungstechnik AG
    Operator Number
    10043460
    Address
    Allmendstrasse 47
    City
    Fehraltorf
    State
    Zurich
    Postal Code
    8320
    Country
    CH
    Correspondent
    Regina Bruggisser

    US Agent

    Business Name
    Fruh Packaging Inc.
    Contact Name
    Jeffrey Zoleta
    Address
    240 Sierra Drive
    City
    Exton
    State
    PA
    ZIP
    19341
    Country
    US
    Email
    [email protected]
    Phone
    267 4993244

    Products

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

    Proprietary Names

    Polarstem

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)