510(k) K222820

BRM TOOL Screws, BIOPLAN Subtalar Implant by Brm Extremities — Product Code HWC

K222820 is an FDA 510(k) premarket notification submitted by Brm Extremities for the device "BRM TOOL Screws, BIOPLAN Subtalar Implant". The FDA issued a decision of Substantially Equivalent on December 16, 2022. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. Brm Extremities has at least 3 other 510(k) clearances on record.