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

    SUPER QUICKANCHOR PLUS (WITH ORTHOCORD SUTURE)

    K Number: K052631 · Decision Oct 21, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    245
    Registration Numbers
    245
    Same Product Code
    230
    Applicant Total
    58
    Review Days
    25

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    Basic Information

    Device Name
    SUPER QUICKANCHOR PLUS (WITH ORTHOCORD SUTURE)
    K Number
    K052631
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Depuy Mitek, A Johnson & Johnson Company
    Date Received
    September 26, 2005
    Decision Date
    October 21, 2005
    Product Code
    JDR
    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
    JDR Staple, Fixation, Bone

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