Stryker Customized Mandible Recon Plate Kit

Stryker Customized Mandible Recon Plate Kit is an FDA 510(k)-cleared medical device (K193136) manufactured by Stryker. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 25, 2020. Regulation: 8.