
Medacta International S.A.
Free shipping on orders over $99 · 30-day returns
VERSAFIT CUP DOUBLE MOBILITY SYSTEM is an FDA 510(k)-cleared medical device (K083116) manufactured by Medacta International S.A.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 6, 2009. Regulation: 8.