510(k) K053528

SHORT CITATION FEMORAL STEM by Stryker Orthopaedics — Product Code MEH

K053528 is an FDA 510(k) premarket notification submitted by Stryker Orthopaedics for the device "SHORT CITATION FEMORAL STEM". The FDA issued a decision of Substantially Equivalent on January 13, 2006. The device falls under product code MEH (Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate), a Class II device regulated under 21 CFR 888.3353. Stryker Orthopaedics has at least 10 other 510(k) clearances on record.