Product code PQC

Device name

Pedicle Screw Placement Guide

Medical specialty

Orthopedic

Device class

2

Regulation number

888.3070

Review panel

OR

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

Definition

A pedicle screw placement guide is intended to be used as a surgical instrument to assist in the intra-operative placement of pedicle screws that are used to anchor pedicle screw spinal systems onto 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