510(k) K131454

KLASSIC HD(TM) EXTENDED OFFSET FEMORAL HEAD by Total Joint Orthopedics, Inc. — Product Code LPH

K131454 is an FDA 510(k) premarket notification submitted by Total Joint Orthopedics, Inc. for the device "KLASSIC HD(TM) EXTENDED OFFSET FEMORAL HEAD". The FDA issued a decision of Substantially Equivalent on February 12, 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. Total Joint Orthopedics, Inc. has at least 10 other 510(k) clearances on record.