Device Dossier
VELOX ACP Spine System - Spinal fixation plate, non-biodegradable
Device Dossier for VELOX ACP Spine System - Spinal fixation plate, non-biodegradable (Spinal fixation plate, non-biodegradable, Class IIb, sponsor…
- GMDN category: Spinal fixation plate, non-biodegradable
Intended purpose
This System is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to C7). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), spondylolisthesis, trauma (i.e. fractures or dislocations), tumors, deformity, pseudarthrosis, failed previous fusion, spinal stenosis.