Osteotech claims US first for spinal replacement device
This article was originally published in Clinica
Osteotech has received US FDA 510(k) clearance to market its VBR (vertebral body replacement) device for use in the thoracolumbar spine (T1-L5). The product, which is manufactured by Ulrich of Ulm, Germany, will be used to replace a vertebral body which has collapsed, become damaged or unstable because of a tumour or trauma, ie fracture. The Eatontown, New Jersey-based company believes that the clearance represents the first time the FDA has specifically cleared any single device for either of these indications.
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