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

    RMS K-WIRE

    K Number: K963367 · Decision Oct 30, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    283
    Registration Numbers
    283
    Same Product Code
    203
    Applicant Total
    10
    Review Days
    64

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    Basic Information

    Device Name
    RMS K-WIRE
    K Number
    K963367
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3040
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Rms Div.
    Date Received
    August 27, 1996
    Decision Date
    October 30, 1996
    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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