510(k) K032548

IP-XS COMPRESSION NAIL SYSTEM by Plus Orthopedics — Product Code HSB

K032548 is an FDA 510(k) premarket notification submitted by Plus Orthopedics for the device "IP-XS COMPRESSION NAIL SYSTEM". The FDA issued a decision of Substantially Equivalent on September 10, 2003. The device falls under product code HSB (Rod, Fixation, Intramedullary And Accessories), a Class II device regulated under 21 CFR 888.3020. Plus Orthopedics has at least 10 other 510(k) clearances on record.