OSSIOfiber Compression Screw, 3.5mm

OSSIOfiber Compression Screw, 3.5mm is a medical device manufactured by OSSIO , Ltd.. It received FDA 510(k) clearance on 2021-12-21 under approval number K213596. 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.