510(k) K050937

TRABECULAR METAL ACETABULAR REVISION SHELLS by Zimmer Trabecular — Product Code LPH

K050937 is an FDA 510(k) premarket notification submitted by Zimmer Trabecular for the device "TRABECULAR METAL ACETABULAR REVISION SHELLS". The FDA issued a decision of Substantially Equivalent on May 11, 2005. The device falls under product code LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented), a Class II device regulated under 21 CFR 888.3358. Zimmer Trabecular has at least 9 other 510(k) clearances on record.