QSD

Posterior Cervical Screw Placement Guide

Product code

QSD

Device name

Posterior Cervical Screw Placement Guide

Device class

Class 2

21 CFR

21 CFR 888.3075

Medical specialty

Orthopedic

Marketing pathway

510(K)

510(k) clearances (last 3 years)

2

FDA classification definition

A posterior cervical screw placement guide is intended to be used as a surgical instrument to assist in the intra-operative placement of posterior cervical screws that are used to anchor posterior cervical screw systems on the posterior elements of the spine. The device utilizes anatomic landmarks that are identifiable on pre-operative imaging scans.

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

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2023-12-07.

1 summaries are archived here for direct download.