QWL — Intraoperative Surgical Angle Measurement Tool Class II

FDA Device Classification

Classification Details

Product Code
QWL
Device Class
Class II
Regulation Number
888.4560
Submission Type
Review Panel
OR
Medical Specialty
Orthopedic
Implant
Yes

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.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K252615ruthless, llc dba ruthless spineRuthless Spine RJBSeptember 17, 2025
K243375ruthless, llc dba ruthless spineRuthless Spine RJBNovember 29, 2024
DEN230012ruthless, llc dba ruthless spineRuthless Spine RJBJuly 14, 2023