BEUDAMED
    Product Code: OXB FDA class 2 21 CFR 878.3300

    Mesh, Surgical, Collagen, Thoracic, Chest Wall Reconstruction

    General, Plastic Surgery

    The Mesh, Surgical, Collagen, Thoracic, Chest Wall Reconstruction is a collagen-based surgical mesh implant used for reinforcement of soft tissue where weakness exists during chest wall reconstruction procedures. It is classified as Class 2 (FDA Class 2), requiring 510(k) premarket clearance. The product code is OXB, with regulation number 878.3300 under the General, Plastic Surgery medical specialty, and it carries an implant flag.

    View on FDA
    510(k)s
    0
    FEI Numbers
    8
    Registration Numbers
    8
    Unique Applicants
    0
    Years Active
    —

    Research product code OXB 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
    OXB
    Device Class
    FDA class 2
    Regulation Number
    878.3300
    Medical Specialty
    General, Plastic Surgery
    Review Panel
    SU
    Submission Type
    1

    Device Characteristics

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

    Definition

    For reinforcement of soft tissue where weakness exists during chest wall reconstruction.

    FEI Numbers

    This FDA classification entry is associated with 8 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 8 registration numbers. Click on an entry to view related FDA registrations.