Identity™ Imprint™ CR KRS and Identity™ Imprint™ PS KRS

Identity™ Imprint™ CR KRS and Identity™ Imprint™ PS KRS is an FDA 510(k)-cleared medical device (K231233) manufactured by Conformis, Inc.. 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 25, 2023. Regulation: 8.