BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Accolade HFX Femoral Stem

    Reg #: 3000196378 · FEI: 3000196378 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    Polymer Corporation
    Registration Number
    3000196378
    FEI Number
    3000196378
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    35 Industrial Park Pl
    City
    Middletown
    State
    CT
    ZIP
    06457
    Country
    US

    Regulatory Submissions

    510(k) Number
    K051741

    Owner / Operator

    Firm Name
    Polymer Corporation
    Operator Number
    10087484
    Address
    35 Industrial Park Place
    City
    Middletown
    State
    CT
    Postal Code
    06457
    Country
    US
    Correspondent
    James Ryan

    Products

    Device Name Product Code
    Prosthesis, Hip, Hemi-, Femoral, Metal KWL
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented LWJ
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented LZO

    Proprietary Names

    Accolade HFX Femoral Stem

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)