Altus Spine Granted FDA Clearance for Sochi OCT System

By Julie A. Vetalice

Altus Spine Granted FDA Clearance for Sochi OCT System

Altus Spine received FDA 510(k) clearance to market its Sochi OCT system. Sochi OCT comprises polyaxial screws, hooks, rods, locking screw assemblies and connectors which can be rigidly locked together in a variety of configurations to promote fusion for a variety of patient anatomies.

Sochi OCT is indicated to promote fusion of the occipito-cervico-thoracic regions of the spine. According to Altus Spine, the intended indications are degenerative disc disease, spondylolisthesis, spinal stenosis, fracture/dislocation, deformities or curvature, tumours, pseudarthrosis, atlanto/axial fracture with instability, occipitocervical dislocation and revision of previous cervical and upper thoracic spine surgery.

The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic spine. The system can also be linked to the company’s Monaco pedicle screw with the use of transition rods and rod connectors.

Source: Altus Spine

 

Product Labels: Spinal Fusion

Tags: 510(k) Clearance, Regulatory