510(k) K170910

Medacta Anatomic Shoulder Prosthesis by Medacta International S.A. — Product Code KWS

K170910 is an FDA 510(k) premarket notification submitted by Medacta International S.A. for the device "Medacta Anatomic Shoulder Prosthesis". The FDA issued a decision of Substantially Equivalent on Aug 16, 2017. The device falls under product code KWS (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented), a Class II device regulated under 21 CFR 888.3660. Medacta International S.A. has 207 other 510(k) clearances on record.