510(k) K243809

Biolox® Delta Revision heads by Limacorporate — Product Code LZO

K243809 is an FDA 510(k) premarket notification submitted by Limacorporate for the device "Biolox® Delta Revision heads". The FDA issued a decision of Substantially Equivalent on March 4, 2025. 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. Limacorporate has at least 3 other 510(k) clearances on record.