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

    BONE BAND

    K Number: K983685 · Decision Dec 4, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    8
    Applicant Total
    1
    Review Days
    45

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    Basic Information

    Device Name
    BONE BAND
    K Number
    K983685
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Chapel and Assoc.
    Date Received
    October 20, 1998
    Decision Date
    December 4, 1998
    Product Code
    LYT
    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
    LYT Fixation Accessory

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