FDA product code QNN: Prosthesis, Total Talus Replacement, Metal
QNN is the FDA product code for prosthesis, total talus replacement, metal. It is a HDE device, reviewed by the Orthopedic panel. Devices under QNN reach the market by Unclassified; FDA lists no cleared 510(k)s for it.
Definition
Replaces the native talus
Classification
| Field | Value |
|---|---|
| Device name | Prosthesis, Total Talus Replacement, Metal |
| Device class | HDE |
| Review panel | OR — Orthopedic |
| Medical specialty | Unknown |
| Premarket route | Unclassified |
| Implant | Yes |
Recalls for QNN devices
openFDA lists no recalls for product code QNN.
Frequently asked questions
What is FDA product code QNN?
QNN is the FDA product code for prosthesis, total talus replacement, metal. It is a HDE device, reviewed by the Orthopedic panel.
What device class is QNN?
HDE. Typical premarket route: Unclassified.
Next steps
- Run an FDA pathway report with predicate devices for product code QNN
- Run a recall and safety report across every QNN manufacturer
- Watch product code QNN for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.