510(k) K063816

PCA ALUMINA FEMORAL HEADS by Stryker Orthopaedics — Product Code LZO

K063816 is an FDA 510(k) premarket notification submitted by Stryker Orthopaedics for the device "PCA ALUMINA FEMORAL HEADS". The FDA issued a decision of Substantially Equivalent on February 2, 2007. The device falls under product code LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented), a Class II device regulated under 21 CFR 888.3353. Stryker Orthopaedics has at least 10 other 510(k) clearances on record.