510(k) K170763

Gentrix Surgical Matrix Thick; Gentrix Surgical Matrix Extend by Acell, Inc. — Product Code FTM

K170763 is an FDA 510(k) premarket notification submitted by Acell, Inc. for the device "Gentrix Surgical Matrix Thick; Gentrix Surgical Matrix Extend". The FDA issued a decision of Substantially Equivalent on June 8, 2017. The device falls under product code FTM (Mesh, Surgical), a Class II device regulated under 21 CFR 878.3300. Acell, Inc. has at least 10 other 510(k) clearances on record.