US clearance for Inion's spinal fusion products
This article was originally published in Clinica
Executive Summary
The US FDA has granted 510(k) clearance for three of Inion's biodegradable spinal fusion products. The Inion S-1 anterior cervical fusion system, the Inion S-1 double-level plate and the Inion S-2 anterior thoraco-lumbar fusion system are plates and screws designed for bone graft containment in spinal fusion procedures, which are carried out for a range of spinal conditions. Unlike traditional metal implants, the Tampere, Finland firm's products completely degrade into carbon dioxide and water. The devices also incorporate a radiographic marker which allows surgeons to view the implants' position using X-ray. The S-1 and S-2 graft containment systems were CE marked for sale in Europe in August and September 2007, respectively.
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