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

    MICROPERFORATION INSTRUMENT

    K Number: K001507 · Decision Jun 14, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    1140
    Registration Numbers
    1140
    Same Product Code
    57
    Applicant Total
    423
    Review Days
    30

    Basic Information

    Device Name
    MICROPERFORATION INSTRUMENT
    K Number
    K001507
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    888.4540
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    SMITH & NEPHEW, INC.
    Date Received
    May 15, 2000
    Decision Date
    June 14, 2000
    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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