510(k) K011567

TORNIER TOTAL ELBOW PROSTHESIS by Tornier — Product Code JDB

K011567 is an FDA 510(k) premarket notification submitted by Tornier for the device "TORNIER TOTAL ELBOW PROSTHESIS". The FDA issued a decision of Substantially Equivalent on June 19, 2001. The device falls under product code JDB (Prosthesis, Elbow, Semi-Constrained, Cemented), a Class II device regulated under 21 CFR 888.3160. Tornier has at least 10 other 510(k) clearances on record.