Device Dossier
Spinal bone screw, non-biodegradable
Device Dossier for Spinal bone screw, non-biodegradable (Spinal bone screw, non-biodegradable, Class IIb, sponsor Spineart). ARTG record, intended…
- GMDN category: Spinal bone screw, non-biodegradable
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; · scoliosis; · kyphosis; · spinal tumor; · and failed previous fusion (pseudarthrosis).