QFP
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Intraoperative Orthopedic Strain Sensor
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3090
- Medical specialty
- Orthopedic
- FDA 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.
Download CSV table Client report (share link) ◉ Watch
Both buttons carry the same predicate table: the CSV downloads for your worksheet, the report is a shareable page for clients. Exports: 3 free/month with an account · reports & watching free.
Building a predicate table? Click + Add on candidates below (up to 8), then compare and export from your Builder.
| Record | Firm | Date | Builder |
|---|---|---|---|
| LOADPRO™ Intraoperative Rod Strain Sensor (DEN180012) | Intellirod Spine, Inc. | 2019-03-28 |
Track QFP automatically
Every clearance here is in the API, with alerts when new ones post.