iTotal Family Reusable Instrument Tray

iTotal Family Reusable Instrument Tray is an FDA 510(k)-cleared medical device (K170226) manufactured by Conformis, Inc.. This device is classified under the General Hospital specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 24, 2017. Regulation: 8.