510(k) K915350

HYDROXYAPATITE INFINITY TROCHANTERIC MODULE by Dow Corning Wright — Product Code MEH

K915350 is an FDA 510(k) premarket notification submitted by Dow Corning Wright for the device "HYDROXYAPATITE INFINITY TROCHANTERIC MODULE". The FDA issued a decision of Substantially Equivalent on February 3, 1992. The device falls under product code MEH (Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate), a Class II device regulated under 21 CFR 888.3353. Dow Corning Wright has at least 10 other 510(k) clearances on record.