BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Prosthesis, Ankle, Uncemented, Non-Constrained

    PMA: P050050 · Supplement: S018 · Decision Apr 19, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18

    Basic Information

    Device Name
    Prosthesis, Ankle, Uncemented, Non-Constrained
    Trade Name
    Scandinavian Total Ankle Replacement (STAR Ankle)
    PMA Number
    P050050
    Supplement Number
    S018
    Device Class
    FDA Class 3
    Product Code
    NTG
    Generic Name
    Prosthesis, ankle, uncemented, non-constrained
    Medical Specialty
    Unknown
    Advisory Committee
    Orthopedic
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    April 19, 2021
    Date Received
    March 24, 2021
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Due to the breakage of the original grinding machine, the old grinding machine is no longer able to function and therefore needs to be replaced.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    NTG Prosthesis, Ankle, Uncemented, Non-Constrained