510(k) DEN230012

Clearance Details

Decision

DENG (De Novo Granted)

Decision Date

July 14, 2023

Date Received

February 16, 2023

Clearance Type

Direct

Expedited Review

No

Third Party Review

No

Device Classification

Device Name

Intraoperative Surgical Angle Measurement Tool

Device Class

Class II

Regulation Number

888.4560

Review Panel

OR

Submission Type

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.