510(k) K003316

OTI CERAMIC FEMORAL HEAD SYSTEM by Osteoimplant Technology, Inc. — Product Code LZO

K003316 is an FDA 510(k) premarket notification submitted by Osteoimplant Technology, Inc. for the device "OTI CERAMIC FEMORAL HEAD SYSTEM". The FDA issued a decision of Substantially Equivalent on January 19, 2001. 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. Osteoimplant Technology, Inc. has at least 10 other 510(k) clearances on record.