510(k) K241241

Z1 Cemented Hip System by Orchard Medical Development, LLC — Product Code LZO

K241241 is an FDA 510(k) premarket notification submitted by Orchard Medical Development, LLC for the device "Z1 Cemented Hip System". The FDA issued a decision of Substantially Equivalent on August 27, 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, LLC has at least 1 other 510(k) clearance on record.