Device Dossier
Surgical procedure kit, neurosurgical, single-use, non-medicated
Device Dossier for Surgical procedure kit, neurosurgical, single-use, non-medicated (Surgical procedure kit, neurosurgical, single-use, non-medicated,…
Intended purpose
The disposable spinal fixation instrument set is intended for pedicle fixation in a percutaneous approach for the following indications: 1)thoracolumbar vertebral fracture, 2)degenerative disc disease, 3)spondylolisthesis, 4)trauma (i.e., fracture or dislocation), 5)spinal stenosis, 6)curvatures, 7)pseudoarthrosis, 8)tumor, 9)failed previous fusion in mature patients 10)The Instrument Set is indicated for stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disc disease (DDD) of the cervical spine, trauma, tumors, deformity, pseudoarthrosis and failed previous fusions.