510(k) K203496

Nexo-Gide Bilayer Collagen Membrane by Geistlich Pharma AG — Product Code FTM

K203496 is an FDA 510(k) premarket notification submitted by Geistlich Pharma AG for the device "Nexo-Gide Bilayer Collagen Membrane". The FDA issued a decision of Substantially Equivalent on July 14, 2021. The device falls under product code FTM (Mesh, Surgical), a Class II device regulated under 21 CFR 878.3300. Geistlich Pharma AG has at least 10 other 510(k) clearances on record.