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

    ENDURAMESH, MODEL 762.XXX

    K Number: K093207 · Decision Apr 26, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    215
    Registration Numbers
    215
    Same Product Code
    275
    Applicant Total
    2
    Review Days
    195

    Basic Information

    Device Name
    ENDURAMESH, MODEL 762.XXX
    K Number
    K093207
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3060
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    LUCERO MEDICAL, LLC
    Date Received
    October 13, 2009
    Decision Date
    April 26, 2010
    Product Code
    MQP
    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
    MQP Spinal Vertebral Body Replacement Device

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    Other Clearances by LUCERO MEDICAL, LLC

    K Number Device Name
    K122622 ENDURAMESH