510(k) K211261

Axis Charcot Fixation System by Extremity Medical, LLC — Product Code HWC

K211261 is an FDA 510(k) premarket notification submitted by Extremity Medical, LLC for the device "Axis Charcot Fixation System". The FDA issued a decision of Substantially Equivalent on May 28, 2021. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. Extremity Medical, LLC has at least 10 other 510(k) clearances on record.