510(k) K093524

PIVIT A/B ST AND PIVIT A/B ST-R by Tyrx, Inc. — Product Code FTL

K093524 is an FDA 510(k) premarket notification submitted by Tyrx, Inc. for the device "PIVIT A/B ST AND PIVIT A/B ST-R". The FDA issued a decision of Substantially Equivalent on March 26, 2010. The device falls under product code FTL (Mesh, Surgical, Polymeric), a Class II device regulated under 21 CFR 878.3300. Tyrx, Inc. has at least 4 other 510(k) clearances on record.