510(k) K111936

ORTHO DEVLOPMENT CERAMIC FEMORAL HEAD by Ortho Development — Product Code LZO

K111936 is an FDA 510(k) premarket notification submitted by Ortho Development for the device "ORTHO DEVLOPMENT CERAMIC FEMORAL HEAD". The FDA issued a decision of Substantially Equivalent on September 21, 2011. 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. Ortho Development has at least 10 other 510(k) clearances on record.