BEUDAMED
    Product Code: QGP FDA not classified

    Posterior Ratcheting Rod System

    Unknown

    The Posterior Ratcheting Rod System is an implantable orthopedic device intended for stabilization or correction of adolescent idiopathic scoliosis without the use of spinal fusion, representing a novel non-fusion approach to scoliosis management. It currently has no FDA classification assigned (unclassified), reviewed by the Orthopedic panel. The product code is QGP with no assigned regulation number. This device carries an implant flag.

    View on FDA
    510(k)s
    0
    FEI Numbers
    3
    Registration Numbers
    3
    Unique Applicants
    0
    Years Active
    —

    Basic Information

    Product Code
    QGP
    Device Class
    FDA not classified
    Medical Specialty
    Unknown
    Review Panel
    OR
    Submission Type
    6

    Device Characteristics

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

    Definition

    Stabilization or correction of adolescent idiopathic scoliosis without the use of fusion.

    Unclassified Reason

    9

    FEI Numbers

    This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.