510(k) K853259

MALLORY/HEAD TOTAL HIP SYSTEM by Biomet, Inc. — Product Code KMC

K853259 is an FDA 510(k) premarket notification submitted by Biomet, Inc. for the device "MALLORY/HEAD TOTAL HIP SYSTEM". The FDA issued a decision of SN on November 1, 1985. The device falls under product code KMC (Prosthesis, Hip, Semi-Constrained, Composite/Metal), a Class II device regulated under 21 CFR 888.3340. Biomet, Inc. has at least 10 other 510(k) clearances on record.