510(k) K252019

CurvaFix Low Profile System by Curvafix, Inc. — Product Code HWC

K252019 is an FDA 510(k) premarket notification submitted by Curvafix, Inc. for the device "CurvaFix Low Profile System". The FDA issued a decision of Substantially Equivalent on August 29, 2025. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. Curvafix, Inc. has at least 2 other 510(k) clearances on record.