510(k) K243195

Arthrex SS VAL and VAL KreuLock™ Compression Screw System by Arthrex, Inc. — Product Code HWC

K243195 is an FDA 510(k) premarket notification submitted by Arthrex, Inc. for the device "Arthrex SS VAL and VAL KreuLock™ Compression Screw System". The FDA issued a decision of Substantially Equivalent on January 10, 2025. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. Arthrex, Inc. has at least 10 other 510(k) clearances on record.