510(k) K103104

SPECIAL ORTHOPAEDIC SOLUTIONS GLENOID SHOULDER COMPONENT by Howmedica Osteonics Corp. — Product Code KWS

K103104 is an FDA 510(k) premarket notification submitted by Howmedica Osteonics Corp. for the device "SPECIAL ORTHOPAEDIC SOLUTIONS GLENOID SHOULDER COMPONENT". The FDA issued a decision of Substantially Equivalent on November 22, 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. Howmedica Osteonics Corp. has at least 10 other 510(k) clearances on record.