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

    AME UNIVERSAL FIXATION SYSTEM

    K Number: K931381 · Decision Feb 1, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    321
    Registration Numbers
    321
    Same Product Code
    429
    Applicant Total
    14
    Review Days
    685

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    Basic Information

    Device Name
    AME UNIVERSAL FIXATION SYSTEM
    K Number
    K931381
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3050
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    American Medical Electronics, Inc.
    Date Received
    March 18, 1993
    Decision Date
    February 1, 1995
    Product Code
    KWP
    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
    KWP Appliance, Fixation, Spinal Interlaminal

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