Device Dossier

Bone-screw internal spinal fixation system connector

Device Dossier for Bone-screw internal spinal fixation system connector (Bone-screw internal spinal fixation system connector, Class IIb, sponsor…

Intended purpose

The PERLA® TL Posterior Thoraco-lumbar Fixation System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: · degenerative disc disease; · spondylolisthesis; · fracture; · dislocation; · spinal tumor; · kyphosis · and failed previous fusion (pseudarthrosis).

TGA Public Summary