510(k) K252615

Clearance Details

Decision

SESE (Substantially Equivalent)

Decision Date

September 17, 2025

Date Received

August 19, 2025

Clearance Type

Special

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.