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Medical Devices / Submissions and Approvals

DePuy Synthes Gains FDA Clearance for Two Cement-Augmented Pedicle Screw Systems

Jan. 27, 2017
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Raynham, Mass,–based, DePuy Synthes has won FDA marketing clearance for its Viper and Expedium fenestrated screw systems.

When used with Confidence high viscosity spinal cement, the screws are intended to restore the integrity of the spinal column in patients with advanced stage spinal tumors.

The device systems may be used in open or percutaneous spinal fusion surgery.

Both products will be available in the U.S. in mid-2017. — Cynthia Jessup

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