BEUDAMED
    Product Code: QUW FDA class 2 21 CFR 878.3300

    Mesh, Surgical, Non-Resorbable, Orthopedics, Reinforcement Of Ligament

    General, Plastic Surgery

    The Non-Resorbable Orthopedic Surgical Mesh for Ligament Reinforcement is a permanent implantable mesh device used to reinforce weakened or repaired soft tissue in ligament repair procedures in orthopedic surgery, providing mechanical augmentation where tissue integrity is compromised. Classified as FDA Class 2 under regulation 878.3300, it requires 510(k) clearance and is reviewed under the Orthopedic panel with a General and Plastic Surgery specialty designation. The device is flagged as an implant given its permanent placement in the body and is not life-sustaining.

    View on FDA
    510(k)s
    4
    FEI Numbers
    5
    Registration Numbers
    5
    Unique Applicants
    3
    Years Active
    3

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    Basic Information

    Product Code
    QUW
    Device Class
    FDA class 2
    Regulation Number
    878.3300
    Medical Specialty
    General, Plastic Surgery
    Review Panel
    OR
    Submission Type
    1

    Device Characteristics

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

    Definition

    a non-resorbable orthopedic mesh used for reinforcement of soft tissue where weakness exists in ligament repair.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 4 510(k) clearances via K numbers.

    K Number Device Name
    K261621 TekBrace Solo Soft Tissue Reinforcement Device
    K242237 Jewel Soft Tissue Reinforcement Device (102-6005)
    K251063 TekBrace Solo Soft Tissue Reinforcement Device
    K222978 Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device

    FEI Numbers

    This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.