QWL

Intraoperative Surgical Angle Measurement Tool

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (2)

Last three years. Most recent: 2025-09-17.

NumberDecision dateApplicantDevice nameSummary
K2526152025-09-17Ruthless, LLC Dba Ruthless SpineRuthless Spine RJBPDF
K2433752024-11-29Ruthless, LLC Dba Ruthless SpineRuthless Spine RJBPDF

2 summaries are archived here for direct download.

Official FDA classification page: QWL
Classification and pathway per current FDA publications. Data from openFDA (CC0).