510(k) K242348

Locking Screw,CoCrMo by Double Medical Technology, Inc. — Product Code HWC

K242348 is an FDA 510(k) premarket notification submitted by Double Medical Technology, Inc. for the device "Locking Screw,CoCrMo". The FDA issued a decision of Substantially Equivalent on December 4, 2024. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. Double Medical Technology, Inc. has at least 10 other 510(k) clearances on record.