BEUDAMED
    FDA Registration Active 🇺🇸 United States

    R3 Acetabular System

    Reg #: 3008744062 · FEI: 3008744062 · Expires 2025
    View on FDA
    Products
    8
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    8

    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
    K240783

    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
    Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate MEH
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented JDI
    Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented KWY
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented LWJ
    Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous MBL
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented LZO
    Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer KWZ

    Proprietary Names

    R3 Acetabular System Anthology Hip Stems Synergy Hip Stems Spectron Hip Stems CPCS Hip Stems Femoral Heads

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility