510(k) K192710

The Simple Locking Intramedullary (Slim) System by Pega Medical, Inc. — Product Code HSB

K192710 is an FDA 510(k) premarket notification submitted by Pega Medical, Inc. for the device "The Simple Locking Intramedullary (Slim) System". The FDA issued a decision of Substantially Equivalent on June 24, 2020. 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.