510(k) K162965

SurgiMend MP Collagen Matrix for Soft Tissue Reconstruction by Tei Biosciences, Inc. — Product Code FTM

K162965 is an FDA 510(k) premarket notification submitted by Tei Biosciences, Inc. for the device "SurgiMend MP Collagen Matrix for Soft Tissue Reconstruction". The FDA issued a decision of Substantially Equivalent on February 16, 2017. The device falls under product code FTM (Mesh, Surgical), a Class II device regulated under 21 CFR 878.3300. Tei Biosciences, Inc. has at least 10 other 510(k) clearances on record.