510(k) K243444

BIOCERAM AZUL® HEAD by Kyocera Corporation — Product Code LZO

K243444 is an FDA 510(k) premarket notification submitted by Kyocera Corporation for the device "BIOCERAM AZUL® HEAD". The FDA issued a decision of Substantially Equivalent on Dec 5, 2024. 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.