510(k) K171010

Latitude EV Total Elbow Arthroplasty by Tornier, Inc. — Product Code JDB

K171010 is an FDA 510(k) premarket notification submitted by Tornier, Inc. for the device "Latitude EV Total Elbow Arthroplasty". The FDA issued a decision of Substantially Equivalent on August 31, 2017. The device falls under product code JDB (Prosthesis, Elbow, Semi-Constrained, Cemented), a Class II device regulated under 21 CFR 888.3160. Tornier, Inc. has at least 10 other 510(k) clearances on record.