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

    WAVEON FRACTURE REPAIR SYSTEM (WAVEON RX)

    K Number: K092110 · Decision Jan 20, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    295
    Registration Numbers
    295
    Same Product Code
    505
    Applicant Total
    9
    Review Days
    190

    Basic Information

    Device Name
    WAVEON FRACTURE REPAIR SYSTEM (WAVEON RX)
    K Number
    K092110
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3020
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    SONOMA ORTHOPEDIC PRODUCTS, INC.
    Date Received
    July 14, 2009
    Decision Date
    January 20, 2010
    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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