510(k) K233396

Cannulated Screw System by Smith & Nephew, Inc. — Product Code HWC

K233396 is an FDA 510(k) premarket notification submitted by Smith & Nephew, Inc. for the device "Cannulated Screw System". The FDA issued a decision of Substantially Equivalent on December 21, 2023. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. Smith & Nephew, Inc. has at least 10 other 510(k) clearances on record.