QWL
- Product code
- QWL
- Device name
- Intraoperative Surgical Angle Measurement Tool
- Device class
- Class 2
- 21 CFR
- 21 CFR 888.4560
- Medical specialty
- Orthopedic
- Marketing pathway
- 510(K)
- Flag
- Implant
- 510(k) clearances (last 3 years)
- 2
- Summaries archived here
- 2 (direct download)
- 510(k) clearances (all years, FDA)
- 3 (all years; only the last 3 years are listed here)
FDA classification definition
An intraoperative surgical angle measurement tool attaches to surgical instruments to measure the angle of the instrument relative to a vertical plumb line in line with gravity. The tool does not utilize anatomic landmarks or registration to patient anatomy.
510(k) clearances, last 3 years (2)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K252615 | 2025-09-17 | Ruthless, LLC Dba Ruthless Spine | Ruthless Spine RJB | |
| K243375 | 2024-11-29 | Ruthless, LLC Dba Ruthless Spine | Ruthless Spine RJB |
Official FDA classification page: QWL
Classification and pathway per current FDA publications. Data from openFDA (CC0).