DeviceClearance

Product code QWL— Orthopedic

Ruthless Spine RJB

Classification name
Intraoperative Surgical Angle Measurement Tool
Device class
Class 2
Regulation
21 CFR 888.4560
Advisory panel
Orthopedic
Total cleared
3
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code QWL under 21 CFR 888.4560, via openFDA

Market context for product code QWL

FDA has cleared 3 devices under product code QWL between 2023 and 2025, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code QWL

Recent clearances under product code QWL

Data sourced from openFDA. This site is unofficial and independent of the FDA.