Device Dossier

TELIX K Interbody System - Spinal cage

Device Dossier for TELIX K Interbody System - Spinal cage (Spinal cage, Class IIb, sponsor Emergo). ARTG record, intended purpose, GMDN category —…

Intended purpose

This System is indicated for use as intervertebral body fusion device in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2 to Sl). Patients should have six months of non-operative treatment prior to surgery. These implants are used to facilitate fusion in the lumbar spine and are placed via a TLIF approach using autogenous bone. These implants are intended for use with Biedermann Motech supplemental internal fixation products.

TGA Public Summary