510(k) K102019

RESTORATION ACETABULAR WEDGE AUGMENTS by Howmedica Osteonics — Product Code LPH

K102019 is an FDA 510(k) premarket notification submitted by Howmedica Osteonics for the device "RESTORATION ACETABULAR WEDGE AUGMENTS". The FDA issued a decision of Substantially Equivalent on March 3, 2011. 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. Howmedica Osteonics has at least 10 other 510(k) clearances on record.