510(k) K240175

Tigon Medical Fractures, Instability, and Reconstruction (FIRE) by Tigon Medical — Product Code HWC

K240175 is an FDA 510(k) premarket notification submitted by Tigon Medical for the device "Tigon Medical Fractures, Instability, and Reconstruction (FIRE)". The FDA issued a decision of Substantially Equivalent on October 29, 2024. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. Tigon Medical has at least 6 other 510(k) clearances on record.