510(k) K152047

INTEGRA TITAN Modular Total Shoulder System Fin-Lock Glenoid by Ascension Orthopedics — Product Code KWS

K152047 is an FDA 510(k) premarket notification submitted by Ascension Orthopedics for the device "INTEGRA TITAN Modular Total Shoulder System Fin-Lock Glenoid". The FDA issued a decision of Substantially Equivalent on December 23, 2015. The device falls under product code KWS (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented), a Class II device regulated under 21 CFR 888.3660. Ascension Orthopedics has at least 10 other 510(k) clearances on record.