Device Dossier

RESONATE Anterior Cervical Plate System - Spinal fixation plate, non-biodegradable

Device Dossier for RESONATE Anterior Cervical Plate System - Spinal fixation plate, non-biodegradable (Spinal fixation plate, non-biodegradable, Class…

Intended purpose

The RESONATE™ Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine (C2-T1) for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (kyphosis, lordosis or scoliosis), pseudarthrosis, failed previous fusions, spondylolisthesis, and spinal stenosis.

TGA Public Summary