BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    THE BONE TIE

    K Number: K982719 · Decision Sep 25, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    283
    Registration Numbers
    283
    Same Product Code
    203
    Applicant Total
    10
    Review Days
    52

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    Basic Information

    Device Name
    THE BONE TIE
    K Number
    K982719
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3040
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Surgicraft , Ltd.
    Date Received
    August 4, 1998
    Decision Date
    September 25, 1998
    Product Code
    HTY
    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
    HTY Pin, Fixation, Smooth

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