BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Prosthesis, Finger, Semi-Constrained, Metal/Polymer

    PMA: P240020 · Supplement: S001 · Decision Sep 5, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Prosthesis, Finger, Semi-Constrained, Metal/Polymer
    Trade Name
    TOUCH® CMC 1 Prosthesis
    PMA Number
    P240020
    Supplement Number
    S001
    Device Class
    FDA Class 3
    Product Code
    SFA
    Generic Name
    Prosthesis, finger, semi-constrained, metal/polymer
    Medical Specialty
    Unknown
    Advisory Committee
    Orthopedic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    September 5, 2025
    Date Received
    August 7, 2025
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Postapproval Study Protocol
    Expedited Review
    N

    Advisory Committee Statement

    Approval of the protocol for the post-approval study (PAS), Continued Long-Term Follow-up Study. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P240020.

    Classifications

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

    Product Code Device Name
    SFA Prosthesis, Finger, Semi-Constrained, Metal/Polymer