510(k) K212996

Sterile PHALINX Hammertoe System by Wrightmedicaltechnologyinc — Product Code HWC

K212996 is an FDA 510(k) premarket notification submitted by Wrightmedicaltechnologyinc for the device "Sterile PHALINX Hammertoe System". The FDA issued a decision of Substantially Equivalent on November 16, 2021. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. Wrightmedicaltechnologyinc has at least 10 other 510(k) clearances on record.