Product code PBJ

Device name

Cranial Distraction System

Medical specialty

Neurology

Device class

2

Regulation number

882.5330

Review panel

NE

Implant

Y

Life sustaining/supporting

Y

GMP exempt

N

Third party review

N

Summary malfunction reporting

Eligible

Definition

A cranial distraction system is a metal device intended to establish osteodistraction and bone growth in the skull. The bone segments are attached to the plate with screws to prevent movement of the segments.

Source

FDA openFDA device classification dataset