DEPUY MOTECH PEAK FIXATION SYSTEM

DEPUY MOTECH PEAK FIXATION SYSTEM is an FDA 510(k)-cleared medical device (K963350) manufactured by Depuy, Inc.. 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 13, 1996. Regulation: 8.