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

    WROBLEWSKI SPRING COMPRESSION WIRE SYSTEM

    K Number: K882890 · Decision Aug 8, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    155
    Registration Numbers
    155
    Same Product Code
    128
    Applicant Total
    5
    Review Days
    28

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    Basic Information

    Device Name
    WROBLEWSKI SPRING COMPRESSION WIRE SYSTEM
    K Number
    K882890
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3010
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Applicant
    Thackray USA
    Date Received
    July 11, 1988
    Decision Date
    August 8, 1988
    Product Code
    JDQ
    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
    JDQ Cerclage, Fixation

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