510(k) K143355

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

K143355 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 July 10, 2015. 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.