BEUDAMED
    FDA Registration Active 🇺🇸 United States

    R3 ANTEVERTED XLPE LINER 32MM X 58MM +4

    Reg #: 3008744062 · FEI: 3008744062 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    88
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Smith & Nephew, Inc.
    Registration Number
    3008744062
    FEI Number
    3008744062
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    7135 Goodlett Farms Pkwy
    City
    Cordova
    State
    TN
    ZIP
    38016
    Country
    US

    Regulatory Submissions

    510(k) Number
    K182535

    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, Uncemented, Metal/Polymer, Porous MBL

    Proprietary Names

    R3 ANTEVERTED XLPE LINER 32MM X 58MM +4 R3 ANTEVERTED XLPE LINER 36MM X 66-70MM +4 R3 ANTEVERTED XLPE LINER 36MM X 60MM +4 R3 ANTEVERTED XLPE LINER 40MM X 66-70MM +4 R3 ANTEVERTED XLPE LINER 40MM X 60MM +4 R3 ANTEVERTED XLPE LINER 32MM X 52MM +4 R3 ANTEVERTED XLPE LINER 40MM X 64MM +4 R3 ANTEVERTED LINER TRIAL 40MM X 66-70MM +4 R3 ANTEVERTED LINER TRIAL 28MM X 50MM +4 R3 ANTEVERTED XLPE LINER 36MM X 52MM +4 R3 ANTEVERTED LINER TRIAL 32MM X 54MM +4 R3 ANTEVERTED LINER TRIAL 36MM X 64MM +4 R3 ANTEVERTED LINER TRIAL 28MM X 44MM +4 R3 ANTEVERTED XLPE LINER 28MM X 54MM +4 R3 ANTEVERTED XLPE LINER 36MM X 50MM +4 R3 ANTEVERTED LINER TRIAL 36MM X 76-80MM +4 R3 ANTEVERTED XLPE LINER 44MM X 64MM +4 R3 ANTEVERTED XLPE LINER 44MM X 72-74MM +4 R3 ANTEVERTED LINER TRIAL 36MM X 66-70MM +4 R3 ANTEVERTED LINER TRIAL 44MM X 66-70MM +4 R3 ANTEVERTED XLPE LINER 40MM X 54MM +4 R3 ANTEVERTED LINER TRAIL 36MM X 50MM +4 R3 ANTEVERTED LINER TRIAL 40MM X 62MM +4 R3 ANTEVERTED XLPE LINER 32MM X 48MM +4 R3 ANTEVERTED XLPE LINER 36MM X 64MM +4 R3 ANTEVERTED XLPE LINER 36MM X 76-80MM +4 R3 ANTEVERTED LINER TRIAL 36MM X 60MM +4 R3 ANTEVERTED LINER TRIAL 40MM X 72-74MM +4 R3 ANTEVERTED LINER TRIAL 36MM X 56MM +4 R3 ANTEVERTED XLPE LINER 28MM X 52MM +4 R3 ANTEVERTED XLPE LINER 32MM X 54MM +4 R3 ANTEVERTED LINER TRIAL 40MM X 58MM +4 R3 ANTEVERTED LINER TRIAL 36MM X 58MM +4 R3 ANTEVERTED LINER TRIAL 40MM X 54MM +4 R3 ANTEVERTED XLPE LINER 40MM X 76-80MM +4 R3 ANTEVERTED LINER TRIAL 40MM X 60MM +4 R3 ANTEVERTED XLPE LINER 28MM X 48MM +4 R3 ANTEVERTED LINER TRIAL 36MM X 52MM +4 R3 ANTEVERTED LINER TRIAL 32MM X 46MM +4 R3 ANTEVERTED LINER TRIAL 44MM X 76-80MM +4 R3 ANTEVERTED XLPE LINER 28MM X 56MM +4 R3 ANTEVERTED XLPE LINER 32MM X 56MM +4 R3 ANTEVERTED LINER TRIAL 44MM X 72-74MM +4 R3 ANTEVERTED LINER TRIAL 40MM X 76-80MM +4 R3 ANTEVERTED XLPE LINER 44MM X 66-70MM +4 R3 ANTEVERTED LINER TRIAL 28MM X 56MM +4 R3 ANTEVERTED XLPE LINER 28MM X 50MM +4 R3 ANTEVERTED XLPE LINER 32MM X 46MM +4 R3 ANTEVERTED XLPE LINER 40MM X 56MM +4 R3 ANTEVERTED LINER TRIAL 32MM X 48MM +4 R3 ANTEVERTED LINER TRIAL 44MM X 62M +4 R3 ANTEVERTED LINER TRIAL 28MM X 46MM +4 R3 ANTEVERTED XLPE LINER 44MM X 62MM +4 R3 ANTEVERTED LINER TRIAL 44MM X 60MM +4 R3 ANTEVERTED XLPE LINER 28MM X 44MM +4 R3 ANTEVERTED LINER TRIAL 32MM X 50MM +4 R3 ANTEVERTED XLPE LINER 32MM X 62MM +4 R3 ANTEVERTED LINER TRIAL 32MM X 62MM +4 R3 ANTEVERTED LINER TRIAL 32MM X 58MM +4 R3 ANTEVERTED LINER TRIAL 36MM X 54MM +4 R3 ANTEVERTED LINER TRIAL 28MM X 52MM +4 R3 ANTEVERTED LINER TRIAL 28MM X 48MM +4 R3 ANTEVERTED LINER TRIAL 44MM X 64MM +4 R3 ANTEVERTED LINER TRIAL 32MM X 52MM +4 R3 ANTEVERTED XLPE LINER 40MM X 72-74MM +4 R3 ANTEVERTED XLPE LINER 40MM X 58MM +4 R3 ANTEVERTED XLPE LINER 40MM X 62MM +4 R3 ANTEVERTED XLPE LINER 44MM X 60MM +4 R3 ANTEVERTED XLPE LINER 28MM X 60MM +4 R3 ANTEVERTED XLPE LINER 28MM X 58MM +4 R3 ANTEVERTED XLPE LINER 36MM X 62MM +4 R3 ANTEVERTED LINER TRIAL 28MM X 58MM +4 R3 ANTEVERTED LINER TRIAL 28MM X 60MM +4 R3 ANTEVERTED XLPE LINER 36MM X 72-74MM +4 R3 ANTEVERTED LINER TRIAL 32MM X 60MM +4 R3 ANTEVERTED XLPE LINER 32MM X 50MM +4 R3 ANTEVERTED LINER TRIAL 28MM X 54MM +4 R3 ANTEVERTED LINER TRIAL 40MM X 56MM +4 R3 ANTEVERTED XLPE LINER 36MM X 58MM +4 R3 ANTEVERTED LINER TRIAL 36MM X 62MM +4 R3 ANTEVERTED XLPE LINER 28MM X 46MM +4 R3 ANTEVERTED LINER TRIAL 36MM X 72-74MM +4 R3 ANTEVERTED LINER TRIAL 32MM X 56MM +4 R3 ANTEVERTED LINER TRIAL 40MM X 64MM +4 R3 ANTEVERTED XLPE LINER 36MM X 56MM +4 R3 ANTEVERTED XLPE LINER 36MM X 54MM +4 R3 ANTEVERTED XLPE LINER 44MM X 76-80MM +4 R3 ANTEVERTED XLPE LINER 32MM X 60MM +4

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility