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

    TARAS THREADED FIXATION PIN

    K Number: K032532 · Decision Oct 22, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    184
    Registration Numbers
    184
    Same Product Code
    93
    Applicant Total
    2
    Review Days
    68

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    Basic Information

    Device Name
    TARAS THREADED FIXATION PIN
    K Number
    K032532
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3040
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Union Surgical, LLC
    Date Received
    August 15, 2003
    Decision Date
    October 22, 2003
    Product Code
    JDW
    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
    JDW Pin, Fixation, Threaded

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