SYNTHECEL DURA REPAIR, SYNTHECEL DURA ONLAY

SYNTHECEL DURA REPAIR, SYNTHECEL DURA ONLAY is an FDA 510(k)-cleared medical device (K131792) manufactured by Synthes, Inc.. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 15, 2013. Regulation: 8.