STRYKER PEDIATRIC MANDIBLE DISTRACTOR

STRYKER PEDIATRIC MANDIBLE DISTRACTOR is an FDA 510(k)-cleared medical device (K133398) 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 19, 2014. Regulation: 8.