Product code QSD

Device name

Posterior Cervical Screw Placement Guide

Medical specialty

Orthopedic

Device class

2

Regulation number

888.3075

Review panel

OR

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

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.

Source

FDA openFDA device classification dataset