510(k) K210062

Mectaplug PE II by Medacta International S.A. — Product Code JDK

K210062 is an FDA 510(k) premarket notification submitted by Medacta International S.A. for the device "Mectaplug PE II". The FDA issued a decision of Substantially Equivalent on April 8, 2021. The device falls under product code JDK (Prosthesis, Hip, Cement Restrictor), a Class II device regulated under 21 CFR 878.3300. Medacta International S.A. has at least 10 other 510(k) clearances on record.