510(k) K183618

Revolution Radial Head by Ignite Orthopedics, Inc. — Product Code KWI

K183618 is an FDA 510(k) premarket notification submitted by Ignite Orthopedics, Inc. for the device "Revolution Radial Head". The FDA issued a decision of Substantially Equivalent on May 17, 2019. The device falls under product code KWI (Prosthesis, Elbow, Hemi-, Radial, Polymer), a Class II device regulated under 21 CFR 888.3170. Ignite Orthopedics, Inc. has at least 2 other 510(k) clearances on record.