ALTA DOME AND PLUNGER (MEC HIP BOLT)

ALTA DOME AND PLUNGER (MEC HIP BOLT) is an FDA 510(k)-cleared medical device (K961213) manufactured by Howmedica Corp.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 12, 1996. Regulation: 8.