Product code NKB

Device name

Thoracolumbosacral Pedicle Screw 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

Intended to provide immobilization and stabilization of spinal segments in thoracic, lumbar, and sacral spine as an adjunct to fusion.

Source

FDA openFDA device classification dataset