510(k) K143276

Acumed Small Bone IM Nail System by Acumed, LLC — Product Code HSB

K143276 is an FDA 510(k) premarket notification submitted by Acumed, LLC for the device "Acumed Small Bone IM Nail System". The FDA issued a decision of Substantially Equivalent on February 5, 2015. The device falls under product code HSB (Rod, Fixation, Intramedullary And Accessories), a Class II device regulated under 21 CFR 888.3020. Acumed, LLC has at least 10 other 510(k) clearances on record.