BEUDAMED
    FDA Registration Active 🇺🇸 United States

    NovoSource Knee System

    Reg #: 3014273644 · FEI: 3014273644 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    NOVOSOURCE, LLC
    Registration Number
    3014273644
    FEI Number
    3014273644
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1000 HAMPTON CTR STE A
    City
    Morgantown
    State
    WV
    ZIP
    26505
    Country
    US

    Regulatory Submissions

    510(k) Number
    K131398

    Owner / Operator

    Firm Name
    NovoSource LLC
    Operator Number
    10056859
    Address
    1000 Hampton Center, Suite A
    City
    Morgantown
    State
    WV
    Postal Code
    26505
    Country
    US

    Products

    Device Name Product Code
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer JWH

    Proprietary Names

    NovoSource Knee System

    Establishment Types

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