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

    OLECRA INTRAMEDULLARY FIXATION SYSTEM

    K Number: K110322 · Decision Mar 4, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    295
    Registration Numbers
    295
    Same Product Code
    505
    Applicant Total
    1
    Review Days
    29

    Basic Information

    Device Name
    OLECRA INTRAMEDULLARY FIXATION SYSTEM
    K Number
    K110322
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3020
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    MYLAD ORTHOPEDIC SOLUTIONS
    Date Received
    February 3, 2011
    Decision Date
    March 4, 2011
    Product Code
    HSB
    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
    HSB Rod, Fixation, Intramedullary And Accessories

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