510(k) K143407

Klassic HD Hip System by Total Joint Othopedics, Inc. — Product Code LZO

K143407 is an FDA 510(k) premarket notification submitted by Total Joint Othopedics, Inc. for the device "Klassic HD Hip System". The FDA issued a decision of Substantially Equivalent on Dec 23, 2014. The device falls under product code LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented), a Class II device regulated under 21 CFR 888.3353. Total Joint Othopedics, Inc. has at least 7 other 510(k) clearances on record.