510(k) K083823

SECURIAN TISSUE REINFORCEMENT MATRIX by Xylos Corporation — Product Code FTM

K083823 is an FDA 510(k) premarket notification submitted by Xylos Corporation for the device "SECURIAN TISSUE REINFORCEMENT MATRIX". The FDA issued a decision of Substantially Equivalent on March 18, 2009. The device falls under product code FTM (Mesh, Surgical), a Class II device regulated under 21 CFR 878.3300. Xylos Corporation has at least 8 other 510(k) clearances on record.