510(k) K213530

Nextra CH Cannulated Hammertoe System by Nextremity Solutions, Inc. — Product Code HWC

K213530 is an FDA 510(k) premarket notification submitted by Nextremity Solutions, Inc. for the device "Nextra CH Cannulated Hammertoe System". The FDA issued a decision of Substantially Equivalent on December 9, 2021. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. Nextremity Solutions, Inc. has at least 10 other 510(k) clearances on record.