Cartiva SCI Disposable Instrumentation Set

Cartiva SCI Disposable Instrumentation Set is an FDA 510(k)-cleared medical device (K181348) manufactured by Cartiva, 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 June 19, 2018. Regulation: 8.