510(k) K922195

OSTEO FEMORAL NAIL by Osteo AG — Product Code HSB

K922195 is an FDA 510(k) premarket notification submitted by Osteo AG for the device "OSTEO FEMORAL NAIL". The FDA issued a decision of Substantially Equivalent on July 23, 1992. The device falls under product code HSB (Rod, Fixation, Intramedullary And Accessories), a Class II device regulated under 21 CFR 888.3020. Osteo AG has at least 8 other 510(k) clearances on record.