510(k) K201393

restor3d MTP Implant by Restor3D, Inc. — Product Code KWD

K201393 is an FDA 510(k) premarket notification submitted by Restor3D, Inc. for the device "restor3d MTP Implant". The FDA issued a decision of Substantially Equivalent on May 25, 2022. The device falls under product code KWD (Prosthesis, Toe, Hemi-, Phalangeal), a Class II device regulated under 21 CFR 888.3730. Restor3D, Inc. has at least 10 other 510(k) clearances on record.