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

    MAESTRO CARPAL HEMIARTHROPLASTY

    K Number: K050028 · Decision Mar 25, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    4
    Applicant Total
    32
    Review Days
    78

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    Basic Information

    Device Name
    MAESTRO CARPAL HEMIARTHROPLASTY
    K Number
    K050028
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3750
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biomet Manufacturing, Inc.
    Date Received
    January 6, 2005
    Decision Date
    March 25, 2005
    Product Code
    KWN
    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
    KWN Prosthesis, Wrist, Carpal Lunate

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