510(k) K926213

MODIFIED ZICKEL INTRAMEDULLARY ROD SYSTEM by Osteo Technology, Inc. — Product Code HSB

K926213 is an FDA 510(k) premarket notification submitted by Osteo Technology, Inc. for the device "MODIFIED ZICKEL INTRAMEDULLARY ROD SYSTEM". The FDA issued a decision of Substantially Equivalent on June 17, 1993. The device falls under product code HSB (Rod, Fixation, Intramedullary And Accessories), a Class II device regulated under 21 CFR 888.3020. Osteo Technology, Inc. has at least 10 other 510(k) clearances on record.