QSR

Sacroiliac Screw Placement Guide

Product code

QSR

Device name

Sacroiliac Screw Placement Guide

Device class

Class 2

21 CFR

21 CFR 888.3040

Medical specialty

Orthopedic

Marketing pathway

510(K)

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).