510(k) K153216

Alpine Cemented Hip System by Ortho Development Corporation — Product Code JDI

K153216 is an FDA 510(k) premarket notification submitted by Ortho Development Corporation for the device "Alpine Cemented Hip System". The FDA issued a decision of Substantially Equivalent on February 18, 2016. The device falls under product code JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented), a Class II device regulated under 21 CFR 888.3350. Ortho Development Corporation has at least 10 other 510(k) clearances on record.