Life Spine’s 510(k) Clearance of CRANIAL FUSION System with SOLSTICE Screws

By Julie A. Vetalice

Life Spine received FDA 510(k) clearance of its CRANIAL FUSION system, expanding indications for use of SOLSTICE Polyaxial Screws into the cervical spine.

The multi-component CRANIAL FUSION system is titanium alloy-based and features occipital plates, occipital bone screws, polyaxial screws, hooks, connectors, rods and locking caps.

For additional levels of fixation, system can be connected to the NAUTILUS®Thoracolumbar Pedicle Screw System using 3.5mm/5.5mm titanium parallel connectors. Hooks and rods are also intended to provide stabilization and promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic spine.

Source: Life Spine

Product Labels: Spinal Fusion

Tags: 510(k) Clearance, Regulatory