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

    EXPENDAGUIDE MULTIPLE HIP PINNING GUIDE SYSTEM

    K Number: K862279 · Decision Jul 25, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    51
    Registration Numbers
    51
    Same Product Code
    37
    Applicant Total
    1
    Review Days
    39

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    Basic Information

    Device Name
    EXPENDAGUIDE MULTIPLE HIP PINNING GUIDE SYSTEM
    K Number
    K862279
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Applicant
    Orthospec, Inc.
    Date Received
    June 16, 1986
    Decision Date
    July 25, 1986
    Product Code
    KTW
    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
    KTW Appliance, Fixation, Nail/Blade/Plate Combination, Single Component

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