ALPINE HIP STEM; ALPINE HA HIP STEM

ALPINE HIP STEM; ALPINE HA HIP STEM is an FDA 510(k)-cleared medical device (K141001) manufactured by Ortho Development. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 29, 2014. Regulation: 8.