BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Prosthesis, Ankle, Uncemented, Non-Constrained

    PMA: P050050 · Supplement: S005 · Decision Jan 24, 2013
    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 SYSTEM (STAR ANKLE)
    PMA Number
    P050050
    Supplement Number
    S005
    Device Class
    FDA Class 3
    Product Code
    NTG
    Generic Name
    Prosthesis, ankle, uncemented, non-constrained
    Medical Specialty
    Unknown
    Advisory Committee
    Orthopedic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    January 24, 2013
    Date Received
    November 13, 2012
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A REVISED PACKAGE INSERT WHICH INCLUDES ADDITIONAL POTENTIAL ADVERSE EVENTS REPORTED IN RECENT STAR ANKLE PUBLICATIONS.

    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