FDA Product Code QWL: Intraoperative Surgical Angle Measurement Tool
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.
Leading manufacturers include Ruthless, LLC Dba Ruthless Spine.
FDA 510(k) Cleared Intraoperative Surgical Angle Measurement Tool Devices (Product Code QWL)
About Product Code QWL - Regulatory Context
510(k) Submission Activity
3 total 510(k) submissions under product code QWL since 2023, with 2 receiving FDA clearance (average review time: 69 days).
Submission volume has increased in recent years - 2 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under QWL have taken an average of 30 days to reach a decision - down from 148 days historically, suggesting improved FDA processing for this classification.
QWL devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →