510(k) K241472

Icona Hip Stem by Corin U.S.A. Limited — Product Code MEH

K241472 is an FDA 510(k) premarket notification submitted by Corin U.S.A. Limited for the device "Icona Hip Stem". The FDA issued a decision of Substantially Equivalent on October 3, 2024. The device falls under product code MEH (Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate), a Class II device regulated under 21 CFR 888.3353. Corin U.S.A. Limited has at least 10 other 510(k) clearances on record.