510(k) K191399

BIOLOX CONTOURA Ceramic Femoral Head by Total Joint Othopedics, Inc. — Product Code LZO

K191399 is an FDA 510(k) premarket notification submitted by Total Joint Othopedics, Inc. for the device "BIOLOX CONTOURA Ceramic Femoral Head". The FDA issued a decision of Substantially Equivalent on Aug 28, 2019. 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.