510(k) K152527

Integra DigiFuse Cannulated Intramedullary Fusion System by Ascension Orthopedics — Product Code HWC

K152527 is an FDA 510(k) premarket notification submitted by Ascension Orthopedics for the device "Integra DigiFuse Cannulated Intramedullary Fusion System". The FDA issued a decision of Substantially Equivalent on October 29, 2015. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. Ascension Orthopedics has at least 10 other 510(k) clearances on record.