510(k) K031449

MODIFICATION TO THE TRABECULAR METAL GLENOID - BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION by Implex Corp. — Product Code KWS

K031449 is an FDA 510(k) premarket notification submitted by Implex Corp. for the device "MODIFICATION TO THE TRABECULAR METAL GLENOID - BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION". The FDA issued a decision of Substantially Equivalent on September 23, 2003. The device falls under product code KWS (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented), a Class II device regulated under 21 CFR 888.3660. Implex Corp. has at least 10 other 510(k) clearances on record.