510(k) K180377

Fracture and Correction System by In2bones USA, LLC — Product Code HWC

K180377 is an FDA 510(k) premarket notification submitted by In2bones USA, LLC for the device "Fracture and Correction System". The FDA issued a decision of Substantially Equivalent on June 20, 2018. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. In2bones USA, LLC has at least 10 other 510(k) clearances on record.