510(k) K160545

GAP ENDO-EXO MEDULLARY SYSTEM by Pega Medical, Inc. — Product Code HSB

K160545 is an FDA 510(k) premarket notification submitted by Pega Medical, Inc. for the device "GAP ENDO-EXO MEDULLARY SYSTEM". The FDA issued a decision of Substantially Equivalent on November 23, 2016. 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.