510(k) K192416

BIOLOX Delta Ceramic Femoral Heads, BIOLOX Option Ceramic Femoral Head System by Zimmer GmbH — Product Code LZO

K192416 is an FDA 510(k) premarket notification submitted by Zimmer GmbH for the device "BIOLOX Delta Ceramic Femoral Heads, BIOLOX Option Ceramic Femoral Head System". The FDA issued a decision of Substantially Equivalent on Oct 1, 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. Zimmer GmbH has 421 other 510(k) clearances on record.