BOLLARD MINIPLATE SKELETAL ANCHORAGE SYSTEM

BOLLARD MINIPLATE SKELETAL ANCHORAGE SYSTEM is an FDA 510(k)-cleared medical device (K091051) manufactured by Tita-Link. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 7, 2009. Regulation: 8.