FDA product code QRU: Implant, Resorbable, For Articular Osteochondral Repair
QRU is the FDA product code for implant, resorbable, for articular osteochondral repair. It is a Class III device, reviewed by the Orthopedic panel. Devices under QRU reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code.
Definition
This device is intended to repair knee joint surface cartilage or osteochondral lesions.
Classification
| Field | Value |
|---|---|
| Device name | Implant, Resorbable, For Articular Osteochondral Repair |
| Device class | Class III |
| Review panel | OR — Orthopedic |
| Medical specialty | Unknown |
| Premarket route | PMA |
| Implant | Yes |
Recalls for QRU devices
openFDA lists no recalls for product code QRU.
Frequently asked questions
What is FDA product code QRU?
QRU is the FDA product code for implant, resorbable, for articular osteochondral repair. It is a Class III device, reviewed by the Orthopedic panel.
What device class is QRU?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code QRU
- Run a recall and safety report across every QRU manufacturer
- Watch product code QRU 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.
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