510(k) K071807

ORTHOMEND SOFT TISSUE MATRIX by Tei Biosciences, Inc. — Product Code FTM

K071807 is an FDA 510(k) premarket notification submitted by Tei Biosciences, Inc. for the device "ORTHOMEND SOFT TISSUE MATRIX". The FDA issued a decision of Substantially Equivalent on August 6, 2007. 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.