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

    NANOSS BIOACTIVE, NANOSS BIOACTIVE LOADED, AND NANOSS BIOACTIVE LOADED KIT

    K Number: K141600 · Decision Oct 17, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    234
    Registration Numbers
    234
    Same Product Code
    483
    Applicant Total
    2
    Review Days
    123

    Basic Information

    Device Name
    NANOSS BIOACTIVE, NANOSS BIOACTIVE LOADED, AND NANOSS BIOACTIVE LOADED KIT
    K Number
    K141600
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3045
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    PIONEER SURGICAL TECHNOLOGY, INC. (RTI SURGICAL, I
    Date Received
    June 16, 2014
    Decision Date
    October 17, 2014
    Product Code
    MQV
    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
    MQV Filler, Bone Void, Calcium Compound

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