510(k) K233476

Z1 Hip System by Orchard Medical Development — Product Code LZO

K233476 is an FDA 510(k) premarket notification submitted by Orchard Medical Development for the device "Z1 Hip System". The FDA issued a decision of Substantially Equivalent on February 8, 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. Orchard Medical Development has at least 1 other 510(k) clearance on record.