QFP — Intraoperative Orthopedic Strain Sensor Class II
FDA product code QFP covers "Intraoperative Orthopedic Strain Sensor", a Class II medical device regulated under 21 CFR 888.3090. Submissions are reviewed by the Orthopedic panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- QFP
- Device Class
- Class II
- Regulation Number
- 888.3090
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN180012 | intellirod spine | LOADPRO Intraoperative Rod Strain Sensor | March 28, 2019 |