Stryker Pediatric Mandibular Distractor 2

Stryker Pediatric Mandibular Distractor 2 is an FDA 510(k)-cleared medical device (K181504) 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 September 10, 2018. Regulation: 8.