510(k) K070278

POLARCUP DUAL MOBILITY SYSTEM by Plus Orthopedics AG — Product Code LPH

K070278 is an FDA 510(k) premarket notification submitted by Plus Orthopedics AG for the device "POLARCUP DUAL MOBILITY SYSTEM". The FDA issued a decision of Substantially Equivalent on April 16, 2007. 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. Plus Orthopedics AG has at least 10 other 510(k) clearances on record.