Product code QWK

Device name

Prosthesis, Posterior Spinal Elements

Medical specialty

Unknown

Device class

3

Review panel

OR

Implant

Y

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

Definition

This device is a non-fusion, load-bearing implanted prosthesis that stabilizes the spine following resection of posterior spinal elements.

Source

FDA openFDA device classification dataset