510(k) K071090

TRABECULAR METAL GLENOID- B/F COMPLETE SHOULDER SOLUTION by Zimmer Trabecular Metal Technology — Product Code KWS

K071090 is an FDA 510(k) premarket notification submitted by Zimmer Trabecular Metal Technology for the device "TRABECULAR METAL GLENOID- B/F COMPLETE SHOULDER SOLUTION". The FDA issued a decision of Substantially Equivalent on June 29, 2007. The device falls under product code KWS (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented), a Class II device regulated under 21 CFR 888.3660. Zimmer Trabecular Metal Technology has at least 10 other 510(k) clearances on record.