510(k) K022377

THE TRABECULAR METAL GLENOID-BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION, MODEL 4306 by Implex Corp. — Product Code KWT

K022377 is an FDA 510(k) premarket notification submitted by Implex Corp. for the device "THE TRABECULAR METAL GLENOID-BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION, MODEL 4306". The FDA issued a decision of Substantially Equivalent on December 10, 2002. The device falls under product code KWT (Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented), a Class II device regulated under 21 CFR 888.3650. Implex Corp. has at least 10 other 510(k) clearances on record.