Device Dossier
Fixation system, internal, spinal, bone screw
Device Dossier for Fixation system, internal, spinal, bone screw (Fixation system, internal, spinal, bone screw, Class IIb, sponsor Nuvasive (Aust/NZ)).…
- GMDN category: Fixation system, internal, spinal, bone screw
Intended purpose
The NuVasive Systems are intended to promote fusion of the cervical spine and occipito-thoracic junction (Occiput-T3), and are indicated for degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture/dislocation, spinal stenosis, atlantoaxial fracture with instability, occipitocervical dislocation, spinal tumor, and/or revision of previous cervical spine surgery.