510(k) K020885

FASSIRE-DUVAL TELESCOPIC IM SYSTEM by Pega Medical, Inc. — Product Code HSB

K020885 is an FDA 510(k) premarket notification submitted by Pega Medical, Inc. for the device "FASSIRE-DUVAL TELESCOPIC IM SYSTEM". The FDA issued a decision of Substantially Equivalent on February 6, 2003. The device falls under product code HSB (Rod, Fixation, Intramedullary And Accessories), a Class II device regulated under 21 CFR 888.3020. Pega Medical, Inc. has at least 10 other 510(k) clearances on record.