Product code QWL

Device name

Intraoperative Surgical Angle Measurement Tool

Medical specialty

Orthopedic

Device class

2

Regulation number

888.4560

Review panel

OR

Implant

Y

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

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.

Source

FDA openFDA device classification dataset