BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Filler, Bone Void, Synthetic Peptide

    PMA: P140019 · Supplement: S003 · Decision Oct 11, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7

    Basic Information

    Device Name
    Filler, Bone Void, Synthetic Peptide
    Trade Name
    i-FACTOR Peptide Enhanced Bone Graft
    PMA Number
    P140019
    Supplement Number
    S003
    Device Class
    FDA Class 3
    Product Code
    NOX
    Generic Name
    Filler, bone void, synthetic peptide
    Medical Specialty
    Unknown
    Advisory Committee
    Orthopedic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    October 11, 2019
    Date Received
    April 17, 2019
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Labeling Change - PAS
    Expedited Review
    N

    Advisory Committee Statement

    Approval for an updated package insert that incorporates the 24-month follow-up data from all subjects enrolled in the original clinical study.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    NOX Filler, Bone Void, Synthetic Peptide