510(k) K844787

BIOMETRIC TOTAL HIP SYSTEM by Biomedics — Product Code JDI

K844787 is an FDA 510(k) premarket notification submitted by Biomedics for the device "BIOMETRIC TOTAL HIP SYSTEM". The FDA issued a decision of Substantially Equivalent on April 19, 1985. The device falls under product code JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented), a Class II device regulated under 21 CFR 888.3350. Biomedics has at least 9 other 510(k) clearances on record.