Spineart Perla receives FDA 510(k) marketing clearance


Spineart has recently received 510(k) clearance from the US Food and Drug Administration (FDA) to market the Perla posterior cervico-thoracic fixation system.

The Perla system is intended for stabilisation of spinal segments as an adjunct to fusion of the cervical spine (C1 to C7) and the thoracic spine (T1 to T3).

Perla features preferred angle lateral mass and smooth shank screws, as well as nine different types of connectors, designed for greater intraoperative flexibility. Transitional rods (cobalt chromium or titanium) are available to extend the construct to the lumbar spine. The instrument set is designed to be ultra-compact, and features multi-functional instruments.