BEUDAMED
    FDA Registration Active 🇨🇭 Switzerland

    POLARSTEM

    Reg #: 9613369 · FEI: 3002807893 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    SMITH & NEPHEW ORTHOPAEDICS AG
    Registration Number
    9613369
    FEI Number
    3002807893
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    SCHACHENALLEE 29, DAMMWEG 39
    City
    AARAU Aargau
    Country
    CH

    Regulatory Submissions

    510(k) Number
    K110135

    Owner / Operator

    Firm Name
    Smith & Nephew, Inc.
    Operator Number
    1020279
    Address
    2875 Railroad Street
    City
    Pittsburgh
    State
    PA
    Postal Code
    15222
    Country
    US
    Correspondent
    Lisa Ewing

    US Agent

    Business Name
    Smith & Nephew Inc.
    Contact Name
    Lisa Ewing
    Address
    2875 Railroad St
    City
    Pittsburgh
    State
    PA
    ZIP
    15222
    Country
    US
    Email
    [email protected]
    Phone
    412 4199765

    Products

    Device Name Product Code
    Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented KWY
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented LPH
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented JDI

    Proprietary Names

    POLARSTEM POLARCUP

    Establishment Types

    Manufacture Medical Device