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

    ACE/KYLE CAPTURED HIP SCREW

    K Number: K813554 · Decision Jan 12, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    249
    Registration Numbers
    249
    Same Product Code
    403
    Applicant Total
    14
    Review Days
    21

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    Basic Information

    Device Name
    ACE/KYLE CAPTURED HIP SCREW
    K Number
    K813554
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Applicant
    Ace Orthopedic Manufacturing Co.
    Date Received
    December 22, 1981
    Decision Date
    January 12, 1982
    Product Code
    KTT
    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
    KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

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    K920738 ACE 100 DEGREES TUBULAR PLATE
    K810193 TRIPPI-WELLS DUAL PURPOSE UNIVERSAL TONG
    K801594 ACE FISCHER EXTERNAL FIXATION DEVICE
    K791466 ACE EXTERNAL BONE CLAMP PART #S11
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