The US Food and Drug Administration (FDA) has accorded its approval for a new Gibralt Occipital Spine System, developed by the US-based Exactech.
The clearance is expected to allow the company to proceed with its plans to make initial launch of the complete Gibralt system in the US market.
The addition of the new device will complete its portfolio of fusion solutions, which according to Exactech, would help clinicians treat the full spine from the occiput, or the back portion of the skull, to the sacrum.
Exactech senior vice president and spine division general manager Bruce Thompson said, "The Gibralt OCT system provides seamless integration with the Proliant 5.5mm and Hydralok 6.0mm Thoraco-Lumbar Pedicle Screw Systems."
The system comprises an occipital plate featuring medial lateral adaptability from 25-45mm, bend zones for easy contouring, low-profile occipital screws and 360° articulating rods - which are believed to provide flexibility in positioning.
Further, the polyaxial screws and cannulated screws in multiple diameters and lengths, hooks, rods, rod-to-rod connectors, offset connectors and cross connectors are claimed to enhance versatility for surgeons.
