510(k) K050101

THE TRABECULAR METAL BONE STABILIZATION IMPLANT, MODEL 99-11197-XX-10 by Zimmer Trabecular — Product Code HRS

K050101 is an FDA 510(k) premarket notification submitted by Zimmer Trabecular for the device "THE TRABECULAR METAL BONE STABILIZATION IMPLANT, MODEL 99-11197-XX-10". The FDA issued a decision of Substantially Equivalent on April 15, 2005. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Zimmer Trabecular has at least 9 other 510(k) clearances on record.