510(k) K252067

Velora Acetabular System by Restor3D, Inc. — Product Code LPH

K252067 is an FDA 510(k) premarket notification submitted by Restor3D, Inc. for the device "Velora Acetabular System". The FDA issued a decision of Substantially Equivalent on December 5, 2025. 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. Restor3D, Inc. has at least 10 other 510(k) clearances on record.