510(k) K160879

CONFIDENCE™ High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated Screw Systems by Medos International Sàrl — Product Code PML

K160879 is an FDA 510(k) premarket notification submitted by Medos International Sàrl for the device "CONFIDENCE™ High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated Screw Systems". The FDA issued a decision of Substantially Equivalent on December 20, 2016. The device falls under product code PML (Bone Cement, Posterior Screw Augmentation), a Class II device regulated under 21 CFR 888.3027. Medos International Sàrl has at least 3 other 510(k) clearances on record.