510(k) K100448

ASCENSION MODULAR TOTAL SHOULDER SYSTEM by Ascension Orthopedics, Inc. — Product Code KWS

K100448 is an FDA 510(k) premarket notification submitted by Ascension Orthopedics, Inc. for the device "ASCENSION MODULAR TOTAL SHOULDER SYSTEM". The FDA issued a decision of Substantially Equivalent on August 30, 2010. 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, Inc. has at least 10 other 510(k) clearances on record.