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 —…
- GMDN category: Spinal cage
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.