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

    LAMINECTOMY ROGEUR

    K Number: K902819 · Decision Aug 9, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    1106
    Registration Numbers
    1106
    Same Product Code
    57
    Applicant Total
    5
    Review Days
    43

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    Basic Information

    Device Name
    LAMINECTOMY ROGEUR
    K Number
    K902819
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    888.4540
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Applicant
    Ruggles Corp.
    Date Received
    June 27, 1990
    Decision Date
    August 9, 1990
    Product Code
    LXH
    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
    LXH Orthopedic Manual Surgical Instrument

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    Other Clearances by Ruggles Corp.

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