510(k) K242896

Caliber Intramedullary Fixation System by Nvision Biomedical Technologies — Product Code HWC

K242896 is an FDA 510(k) premarket notification submitted by Nvision Biomedical Technologies for the device "Caliber Intramedullary Fixation System". The FDA issued a decision of Substantially Equivalent on February 5, 2025. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. Nvision Biomedical Technologies has at least 10 other 510(k) clearances on record.