510(k) K163593

Additive Orthopaedics Bunion System by Additive Orthopaedics, LLC — Product Code HRS

K163593 is an FDA 510(k) premarket notification submitted by Additive Orthopaedics, LLC for the device "Additive Orthopaedics Bunion System". The FDA issued a decision of Substantially Equivalent on June 20, 2017. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Additive Orthopaedics, LLC has at least 6 other 510(k) clearances on record.