510(k) K130353

PIPELINE TOTAL HIP SYSTEM (LINE EXTENSION) by Pipeline Orthopedics — Product Code LPH

K130353 is an FDA 510(k) premarket notification submitted by Pipeline Orthopedics for the device "PIPELINE TOTAL HIP SYSTEM (LINE EXTENSION)". The FDA issued a decision of Substantially Equivalent on July 1, 2013. 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. Pipeline Orthopedics has at least 8 other 510(k) clearances on record.