510(k) K190136

Fusion Silastic System by Fusion Orthopedics, LLC — Product Code KWH

K190136 is an FDA 510(k) premarket notification submitted by Fusion Orthopedics, LLC for the device "Fusion Silastic System". The FDA issued a decision of Substantially Equivalent on October 21, 2019. The device falls under product code KWH (Prosthesis, Toe, Constrained, Polymer), a Class II device regulated under 21 CFR 888.3720. Fusion Orthopedics, LLC has at least 10 other 510(k) clearances on record.