Intraoperative Orthopedic Strain Sensor
The Intraoperative Orthopedic Strain Sensor is an adjunct tool intended to measure strain on an orthopedic implant in the intraoperative setting only; it is not intended to provide diagnostic information or influence clinical decision-making independently. It is classified as FDA Class 2, requiring 510(k) premarket notification under regulation 888.3090 in the Orthopedic specialty. The product code is QFP. It is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- QFP
- Device Class
- FDA class 2
- Regulation Number
- 888.3090
- Medical Specialty
- Orthopedic
- Review Panel
- OR
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| DEN180012 | LOADPRO Intraoperative Rod Strain Sensor | Mar 28, 2019 | Unknown | Intellirod Spine, Inc. |