510(k) K090208

BIOPRO FEMORAL HEADS by Biopro, Inc. — Product Code JDI

K090208 is an FDA 510(k) premarket notification submitted by Biopro, Inc. for the device "BIOPRO FEMORAL HEADS". The FDA issued a decision of Substantially Equivalent on May 22, 2009. The device falls under product code JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented), a Class II device regulated under 21 CFR 888.3350. Biopro, Inc. has at least 10 other 510(k) clearances on record.