510(k) K070787

LATITUDE ELBOW PROTHESIS by Tornier — Product Code JDB

K070787 is an FDA 510(k) premarket notification submitted by Tornier for the device "LATITUDE ELBOW PROTHESIS". The FDA issued a decision of Substantially Equivalent on August 24, 2007. 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.