SAGICO OSI Spinal System by Osimplant

SAGICO OSI Spinal System by Osimplant is an FDA 510(k)-cleared medical device (K180220) manufactured by Spinal Analytics & Geometrical Implant Co, 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 May 20, 2018. Regulation: 8.