FDA product code QFP: Intraoperative Orthopedic Strain Sensor
QFP is the FDA product code for intraoperative orthopedic strain sensor. It is a Class II device, regulated under 21 CFR 888.3090 and reviewed by the Orthopedic panel. Devices under QFP reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.
Definition
A strain sensor device is an adjunct tool intended to measure strain on an orthopedic implant in the intraoperative setting only. The device is not intended to provide diagnostic information or influence clinical decision-making.
Classification
| Field | Value |
|---|---|
| Device name | Intraoperative Orthopedic Strain Sensor |
| Device class | Class II |
| Regulation | 21 CFR 888.3090 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
Recalls for QFP devices
openFDA lists no recalls for product code QFP.
Frequently asked questions
What is FDA product code QFP?
QFP is the FDA product code for intraoperative orthopedic strain sensor. It is a Class II device, regulated under 21 CFR 888.3090 and reviewed by the Orthopedic panel.
What device class is QFP?
Class II, regulation 21 CFR 888.3090. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code QFP
- Run a recall and safety report across every QFP manufacturer
- Watch product code QFP 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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