restor3d Metallic Interference Screw

restor3d Metallic Interference Screw is a medical device manufactured by Restor3D. It received FDA 510(k) clearance on 2020-03-19 under approval number K193491. 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.