SGK

Prosthesis, Spinous Process Tension Band Implant

Product code: SGK
Device name: Prosthesis, Spinous Process Tension Band Implant
Device class: Class 3
Medical specialty: Unknown
Marketing pathway: PMA
Flag: Implant

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

Official FDA classification page: SGK

Classification and pathway per current FDA publications. Data from openFDA (CC0).