510(k) K203090

ELEOS Limb Salvage System featuring BIOGRIP by Onkos Surgical — Product Code JDI

K203090 is an FDA 510(k) premarket notification submitted by Onkos Surgical for the device "ELEOS Limb Salvage System featuring BIOGRIP". The FDA issued a decision of Substantially Equivalent on December 11, 2020. The device falls under product code JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented), a Class II device regulated under 21 CFR 888.3350. Onkos Surgical has at least 10 other 510(k) clearances on record.