510(k) K242833

Legend® Acetabular Shell by Ortho Development Corp. — Product Code LPH

K242833 is an FDA 510(k) premarket notification submitted by Ortho Development Corp. for the device "Legend® Acetabular Shell". The FDA issued a decision of Substantially Equivalent on October 11, 2024. 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. Ortho Development Corp. has at least 10 other 510(k) clearances on record.