510(k) K170214

Additive Orthopaedics Locking Lattice Plate by Additive Orthopaedics, LLC — Product Code HRS

K170214 is an FDA 510(k) premarket notification submitted by Additive Orthopaedics, LLC for the device "Additive Orthopaedics Locking Lattice Plate". The FDA issued a decision of Substantially Equivalent on April 13, 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.