510(k) K193233

Restoration® Modular Hip System by Howmedica Osteonics Corp. (Aka Stryker Orthopaedics) — Product Code LPH

K193233 is an FDA 510(k) premarket notification submitted by Howmedica Osteonics Corp. (Aka Stryker Orthopaedics) for the device "Restoration® Modular Hip System". The FDA issued a decision of Substantially Equivalent on May 27, 2020. 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 Corp. (Aka Stryker Orthopaedics) has 1 other 510(k) clearance on record.