FDA product code QYQ: Prosthesis, Total Talus Replacement With Soft Tissue Attachment Sites, Metal
QYQ is the FDA product code for prosthesis, total talus replacement with soft tissue attachment sites, metal. It is a HDE device, reviewed by the Orthopedic panel. Devices under QYQ 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 With Soft Tissue Attachment Sites, Metal |
| Device class | HDE |
| Review panel | OR — Orthopedic |
| Medical specialty | Unknown |
| Premarket route | Unclassified |
| Implant | Yes |
Recalls for QYQ devices
openFDA lists no recalls for product code QYQ.
Frequently asked questions
What is FDA product code QYQ?
QYQ is the FDA product code for prosthesis, total talus replacement with soft tissue attachment sites, metal. It is a HDE device, reviewed by the Orthopedic panel.
What device class is QYQ?
HDE. Typical premarket route: Unclassified.
Next steps
- Run an FDA pathway report with predicate devices for product code QYQ
- Run a recall and safety report across every QYQ manufacturer
- Watch product code QYQ 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.
All Orthopedic product codes · FDA product code lookup · 510(k) database search · 510(k) review times