510(k) K233261

Global Modular Replacement System by Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics — Product Code JDI

K233261 is an FDA 510(k) premarket notification submitted by Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics for the device "Global Modular Replacement System". The FDA issued a decision of Substantially Equivalent on December 8, 2023. The device falls under product code JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented), a Class II device regulated under 21 CFR 888.3350. Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics has at least 8 other 510(k) clearances on record.