AMS MAINSTAY UROLOGIC BONE ANCHOR

AMS MAINSTAY UROLOGIC BONE ANCHOR is an FDA 510(k)-cleared medical device (K971332) manufactured by American Medical Systems, Inc.. 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 8, 1997. Regulation: 8.