BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    TELOS DISTAL TARGETING DEVICE

    K Number: K880381 · Decision Mar 15, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    92
    Registration Numbers
    92
    Same Product Code
    6
    Applicant Total
    1
    Review Days
    48

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    Basic Information

    Device Name
    TELOS DISTAL TARGETING DEVICE
    K Number
    K880381
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    888.4540
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Applicant
    Austin Assoc.
    Date Received
    January 27, 1988
    Decision Date
    March 15, 1988
    Product Code
    HXY
    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
    HXY Brace, Drill

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