BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Vivacit-E

    Reg #: 3007366790 · FEI: 3007282753 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Smith & Nephew, Inc.
    Registration Number
    3007366790
    FEI Number
    3007282753
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    3303 E Holmes Rd
    City
    Memphis
    State
    TN
    ZIP
    38118
    Country
    US

    Regulatory Submissions

    510(k) Number
    K122529

    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

    Products

    Device Name Product Code
    Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer HSX
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive OIY

    Proprietary Names

    Vivacit-E ZUK

    Establishment Types

    Manufacture Medical Device