510(k) K243466

Conformity Stem Extension Line, #0 by United Orthopedic Corporation — Product Code LZO

K243466 is an FDA 510(k) premarket notification submitted by United Orthopedic Corporation for the device "Conformity Stem Extension Line, #0". The FDA issued a decision of Substantially Equivalent on January 6, 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. United Orthopedic Corporation has at least 10 other 510(k) clearances on record.