510(k) K193547

CustomizedBone Service by Fin-Ceramica Faenza S.P.A. — Product Code GXN

K193547 is an FDA 510(k) premarket notification submitted by Fin-Ceramica Faenza S.P.A. for the device "CustomizedBone Service". The FDA issued a decision of Substantially Equivalent on January 17, 2020. The device falls under product code GXN (Plate, Cranioplasty, Preformed, Non-Alterable), a Class II device regulated under 21 CFR 882.5330. Fin-Ceramica Faenza S.P.A. has at least 4 other 510(k) clearances on record.