Product code SGK

Device name

Prosthesis, Spinous Process Tension Band Implant

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, tension band implant that is intended to provide dynamic flexion-restricting stabilization of the spine following a lumbar decompression.

Source

FDA openFDA device classification dataset