510(k) K212815

My3D® Personalized Pelvic Reconstruction by Onkos Surgical — Product Code LPH

K212815 is an FDA 510(k) premarket notification submitted by Onkos Surgical for the device "My3D® Personalized Pelvic Reconstruction". The FDA issued a decision of Substantially Equivalent on July 6, 2022. The device falls under product code LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented), a Class II device regulated under 21 CFR 888.3358. Onkos Surgical has at least 10 other 510(k) clearances on record.