BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    MAESTRO WRIST FRACTURE IMPLANT

    K Number: K080426 · Decision Jul 29, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    37
    Registration Numbers
    37
    Same Product Code
    16
    Applicant Total
    93
    Review Days
    160

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    Basic Information

    Device Name
    MAESTRO WRIST FRACTURE IMPLANT
    K Number
    K080426
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3800
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biomet Manufacturing Corp
    Date Received
    February 20, 2008
    Decision Date
    July 29, 2008
    Product Code
    JWJ
    Advisory Committee
    Orthopedic
    Review Advisory Committee
    OR
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    JWJ Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained

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