510(k) K951740

INTRAMEDULARY FIXATION ROD by Acu Med, Inc. — Product Code HSB

K951740 is an FDA 510(k) premarket notification submitted by Acu Med, Inc. for the device "INTRAMEDULARY FIXATION ROD". The FDA issued a decision of Substantially Equivalent on August 11, 1995. The device falls under product code HSB (Rod, Fixation, Intramedullary And Accessories), a Class II device regulated under 21 CFR 888.3020. Acu Med, Inc. has at least 10 other 510(k) clearances on record.