REVELATION STEM, MODEL 427-21/42-080/180

REVELATION STEM, MODEL 427-21/42-080/180 is an FDA 510(k)-cleared medical device (K083651) manufactured by Encore Medical L.P.. This device is classified under the Orthopedic specialty. FDA Device Class III (Premarket Approval) — highest risk category. FDA clearance granted on March 12, 2009. Regulation: 8.