BEUDAMED
    Product Code: PBD 21 CFR 878.4024

    Composite Cultured Skin

    General, Plastic Surgery

    The Composite Cultured Skin is an implantable biological skin substitute intended for patients with mitten hand deformities due to Recessive Dystrophic Epidermolysis Bullosa (RDEB), a severe inherited skin fragility disorder. It falls under the General and Plastic Surgery specialty and references regulation 878.4024. The device carries a class of "f," indicating a special or biological regulatory pathway rather than a standard 510(k) or PMA classification. It is flagged as an implant but is not life-sustaining.

    View on FDA
    510(k)s
    0
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    0
    Years Active
    —

    Research product code PBD in seconds

    The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Product Code
    PBD
    Regulation Number
    878.4024
    Medical Specialty
    General, Plastic Surgery
    Review Panel
    SU
    Submission Type
    6

    Device Characteristics

    ✗
    GMP Exempt
    ✓
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    For patients with mitten hand deformities due to Recessive Dystrophic Epidermolysis Bullosa (RDEB)