510(k) K953792

CONSENSUS ZIRCONIA HEAD SIZE -3.5, 0, +5 by U.S. Medical Products, Inc. — Product Code LZO

K953792 is an FDA 510(k) premarket notification submitted by U.S. Medical Products, Inc. for the device "CONSENSUS ZIRCONIA HEAD SIZE -3.5, 0, +5". The FDA issued a decision of SN on November 6, 1995. 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. U.S. Medical Products, Inc. has at least 10 other 510(k) clearances on record.