510(k) K160264

Additive Orthopaedics Hammertoe Correction System by Additive Orthopaedics, LLC — Product Code HTY

K160264 is an FDA 510(k) premarket notification submitted by Additive Orthopaedics, LLC for the device "Additive Orthopaedics Hammertoe Correction System". The FDA issued a decision of Substantially Equivalent on June 1, 2016. The device falls under product code HTY (Pin, Fixation, Smooth), a Class II device regulated under 21 CFR 888.3040. Additive Orthopaedics, LLC has at least 6 other 510(k) clearances on record.