BEUDAMED
    Product Code: QES FDA class 3

    Reherniation Reduction Device

    Unknown

    The Reherniation Reduction Device is an implantable orthopedic device intended to reduce the incidence of reherniation and reoperation following primary limited lumbar discectomy procedures (excision of herniated intervertebral disc). It is classified as FDA Class 3, requiring Premarket Approval (PMA) due to the significant risks associated with spinal implantation and its novel indication. The product code is QES with no assigned regulation number, reviewed by the Orthopedic panel. This device carries an implant flag.

    View on FDA
    510(k)s
    0
    FEI Numbers
    2
    Registration Numbers
    2
    Unique Applicants
    0
    Years Active
    —

    Basic Information

    Product Code
    QES
    Device Class
    FDA class 3
    Medical Specialty
    Unknown
    Review Panel
    OR
    Submission Type
    2

    Device Characteristics

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

    Definition

    The device is intended to reduce the incidence of reherniation, and reoperation following primary limited lumbar discectomy procedures (excision of herniated intervertebral disc).

    FEI Numbers

    This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.