SYNTHES BRAINLAB TRAUMA COMPATIBLE INSTRUMENTS

SYNTHES BRAINLAB TRAUMA COMPATIBLE INSTRUMENTS is an FDA 510(k)-cleared medical device (K111891) manufactured by Synthes (USA) Products, LLC. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 27, 2011. Regulation: 8.