OSSIOfiber™ Compression Screws

OSSIOfiber™ Compression Screws is a medical device manufactured by OSSIO , Ltd.. It received FDA 510(k) clearance on 2020-07-30 under approval number K193660. 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.