510(k) K141001

ALPINE HIP STEM; ALPINE HA HIP STEM by Ortho Development — Product Code LPH

K141001 is an FDA 510(k) premarket notification submitted by Ortho Development for the device "ALPINE HIP STEM; ALPINE HA HIP STEM". The FDA issued a decision of Substantially Equivalent on July 30, 2014. The device falls under product code LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented), a Class II device regulated under 21 CFR 888.3358. Ortho Development has at least 10 other 510(k) clearances on record.