510(k) K083490

BIOPRO K-WIRE, MODELS 16863, 17231, 17232, 18577, 18682-18685 by Biopro, Inc. — Product Code HTY

K083490 is an FDA 510(k) premarket notification submitted by Biopro, Inc. for the device "BIOPRO K-WIRE, MODELS 16863, 17231, 17232, 18577, 18682-18685". The FDA issued a decision of Substantially Equivalent on March 18, 2009. The device falls under product code HTY (Pin, Fixation, Smooth), a Class II device regulated under 21 CFR 888.3040. Biopro, Inc. has at least 10 other 510(k) clearances on record.