BEUDAMED
    Product Code: QNN

    Prosthesis, Total Talus Replacement, Metal

    Unknown

    The Prosthesis for Total Talus Replacement (Metal) is an orthopedic implant intended to replace the native talus bone of the ankle joint, used in cases of severe talar avascular necrosis, fracture, or arthritis where the talus cannot be preserved. The device class is recorded as "f" (transitional or exempt status), with no formal regulation number assigned. Product code QNN, reviewed by the Orthopedic panel. The device is flagged as an implant and is not life-sustaining.

    View on FDA
    510(k)s
    0
    FEI Numbers
    5
    Registration Numbers
    5
    Unique Applicants
    0
    Years Active
    —

    Basic Information

    Product Code
    QNN
    Medical Specialty
    Unknown
    Review Panel
    OR
    Submission Type
    6

    Device Characteristics

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

    Definition

    Replaces the native talus

    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.