BEUDAMED
    FDA Registration Active 🇺🇸 United States

    OR3O Dual Mobility System

    Reg #: 3005551626 · FEI: 3005551626 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    SMITH & NEPHEW, INC.
    Registration Number
    3005551626
    FEI Number
    3005551626
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    6409 E Holmes Rd
    City
    Memphis
    State
    TN
    ZIP
    38141
    Country
    US

    Regulatory Submissions

    510(k) Number
    K242375

    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, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented LPH

    Proprietary Names

    OR3O Dual Mobility System

    Establishment Types

    Manufacture Medical Device