Product code QSR

Device name

Sacroiliac Screw Placement Guide

Medical specialty

Orthopedic

Device class

2

Regulation number

888.3040

Review panel

OR

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

Definition

A sacroiliac screw placement guide is intended to be used as a surgical instrument to assist in the intra-operative placement of sacroiliac screws across the sacroiliac joint. The device utilizes anatomical landmarks that are identifiable on pre-operative imaging scans.

Source

FDA openFDA device classification dataset