510(k) K223348

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

K223348 is an FDA 510(k) premarket notification submitted by Onkos Surgical, Inc. for the device "My3D® Personalized Pelvic Reconstruction". The FDA issued a decision of Substantially Equivalent on January 30, 2023. 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, Inc. has at least 10 other 510(k) clearances on record.