510(k) K183011

Additive Orthopaedics Patient Specific 3D Locking Lattice Plates by Additive Orthopaedics — Product Code HRS

K183011 is an FDA 510(k) premarket notification submitted by Additive Orthopaedics for the device "Additive Orthopaedics Patient Specific 3D Locking Lattice Plates". The FDA issued a decision of Substantially Equivalent on January 10, 2019. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Additive Orthopaedics has at least 6 other 510(k) clearances on record.