QWL

3 FDA 510(k) clearances · Product code

FDA profile

Official device name

Intraoperative Surgical Angle Measurement Tool

Device class

Class II (moderate risk)

Regulation

21 CFR 888.4560

Medical specialty

Orthopedic

Flags

Implant

FDA 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.

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