Orbitum Bone Staple Implant, X and VI

Orbitum Bone Staple Implant, X and VI is an FDA 510(k)-cleared medical device (K173693) manufactured by Orthovestments, LLC. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 22, 2018. Regulation: 8.