BEUDAMED
    FDA Registration Active 🇺🇸 United States

    eCeramic Femoral Heads

    Reg #: 3002498892 · FEI: 3002498892 · Expires 2025
    View on FDA
    Products
    4
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    4

    Registration Details

    Registration Name
    THEKEN COMPANIES, LLC
    Registration Number
    3002498892
    FEI Number
    3002498892
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1800 Triplett Blvd
    City
    Akron
    State
    OH
    ZIP
    44306
    Country
    US

    Regulatory Submissions

    510(k) Number
    K220336

    Owner / Operator

    Firm Name
    Theken Companies, LLC
    Operator Number
    10050903
    Address
    1800 Triplett Blvd
    City
    Akron
    State
    OH
    Postal Code
    44306
    Country
    US
    Correspondent
    Garrett Spurgeon

    Products

    Device Name Product Code
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented LZO
    Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented OQI
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented LPH
    Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented OQG

    Proprietary Names

    eCeramic Femoral Heads

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198