BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Filler, Bone Void, Synthetic Peptide

    PMA: P140019 · Supplement: S013 · Decision Apr 7, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Filler, Bone Void, Synthetic Peptide
    Trade Name
    i-FACTOR® Peptide Enhanced Graft Substitute
    PMA Number
    P140019
    Supplement Number
    S013
    Device Class
    FDA Class 3
    Product Code
    NOX
    Generic Name
    Filler, bone void, synthetic peptide
    Medical Specialty
    Unknown
    Advisory Committee
    Orthopedic
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    April 7, 2026
    Date Received
    April 1, 2026
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Change in the location for performance of the mass spectral analysis for the P-15 drug substance release specification from SGS North America (NAM), Inc, West Chester PA as a contract laboratory to Bachem Americas to being performed inhouse at Bachem Americas, Torrence, CA

    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