POWERGRIP(TM) COMPRESSION FIXATION DEVICE

POWERGRIP(TM) COMPRESSION FIXATION DEVICE is an FDA 510(k)-cleared medical device (K950009) manufactured by Synvasive Technology, 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 August 17, 1995. Regulation: 8.