DART-FIRE EDGE Cannulated Screw System

DART-FIRE EDGE Cannulated Screw System is the device name listed in this FDA 510(k) record. The listed applicant is Wright Medical. It received FDA 510(k) clearance on 2021-05-11 under 510(k) number K203228. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.