510(k) K163627

Shotel Ankle Arthrodesis Nail System by Biopro, Inc. — Product Code HSB

K163627 is an FDA 510(k) premarket notification submitted by Biopro, Inc. for the device "Shotel Ankle Arthrodesis Nail System". The FDA issued a decision of Substantially Equivalent on September 14, 2017. The device falls under product code HSB (Rod, Fixation, Intramedullary And Accessories), a Class II device regulated under 21 CFR 888.3020. Biopro, Inc. has at least 10 other 510(k) clearances on record.