Product code PGM

Device name

Growing Rod System

Medical specialty

Orthopedic

Device class

2

Regulation number

888.3070

Review panel

OR

Implant

Y

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Eligible

Definition

Stabilization or correction of spinal deformities without the use of fusion.

Source

FDA openFDA device classification dataset