ALPHA LONG STEM FEMORAL COMPONENT (SUBJECT TO WMTI MARKETING APPROVAL)

ALPHA LONG STEM FEMORAL COMPONENT (SUBJECT TO WMTI MARKETING APPROVAL) is an FDA 510(k)-cleared medical device (K951139) manufactured by Wrightmedicaltechnologyinc. 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 21, 1995. Regulation: 8.