510(k) K161371

Sonoma Fifth Metatarsal Repair System by Sonoma Orthopedic Products, Inc. — Product Code HSB

K161371 is an FDA 510(k) premarket notification submitted by Sonoma Orthopedic Products, Inc. for the device "Sonoma Fifth Metatarsal Repair System". The FDA issued a decision of Substantially Equivalent on Feb 24, 2017. The device falls under product code HSB (Rod, Fixation, Intramedullary And Accessories), a Class II device regulated under 21 CFR 888.3020. Sonoma Orthopedic Products, Inc. has 8 other 510(k) clearances on record.