510(k) K233134

I.T.S. INS Proximal Femur Nail by I.T.S. GmbH — Product Code HSB

K233134 is an FDA 510(k) premarket notification submitted by I.T.S. GmbH for the device "I.T.S. INS Proximal Femur Nail". The FDA issued a decision of Substantially Equivalent on February 12, 2024. The device falls under product code HSB (Rod, Fixation, Intramedullary And Accessories), a Class II device regulated under 21 CFR 888.3020. I.T.S. GmbH has at least 7 other 510(k) clearances on record.