510(k) K221220

Montross Extremity Medical Hemi Implant System by Montross Extremity Medical — Product Code KWD

K221220 is an FDA 510(k) premarket notification submitted by Montross Extremity Medical for the device "Montross Extremity Medical Hemi Implant System". The FDA issued a decision of Substantially Equivalent on April 19, 2023. The device falls under product code KWD (Prosthesis, Toe, Hemi-, Phalangeal), a Class II device regulated under 21 CFR 888.3730.